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Account Manager Sales-Epicel Denver South, CO - Homebased 01/21/2022

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Sales professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Director, Regional Sales at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

Front line, direct sales position responsible for generating demand for Vericel products and services by fostering HCP interest in, education of, access to, and buy-in at targeted burn centers.  Success measured by goal achievement in alignment with Vericel values.

ESSENTIAL FUNCTIONS

Core Responsibilities:

Direct sales calls to key decision makers at targeted burn centers, including surgeons and support personnel, to engage in the selling process:

  • Connecting with stakeholders to the point of earning trusted advisor status
  • Discovering the current state at targeted accounts specific to burn treatment, including pain points, blind spots, and opportunities for Epicel to bring value
  • Aligning with the key stakeholders regarding their pain points, blind spots, and where Vericel would bring value, assertively and credibly managing objections and misconceptions
  • Advancing the key stakeholders to action, including biopsies of appropriate patients and f/u usage of Epicel with patients for whom it makes sense.

Develop and manage complex accounts via:

  • Identifying and connecting with key stakeholders & support staff (account mapping)
  • Developing and executing key account strategic plans (account planning)
  • Maintaining an appropriate and consistent presence within key accounts among key stakeholders
  • Maintaining complete awareness of evolving patient population and advocating for appropriate Vericel patients.
  • Staying aware of competitive activities and threats
  • Setting accounts up for success with Vericel products by providing or arranging (via BCS) appropriate training and support

Foster access to and procurement of Vericel products:

  • Determining procurement process at each targeted account
  • Leveraging reimbursement and coding expertise to optimize Vericel product coverage
  • Ensuring account approval for Vericel products to the highest levels in key accounts
  • Presenting to VAC and P&T committees

Manage territory for optimal performance and effectiveness

  • Establishing and execute routing that results in appropriate coverage levels according to target emphasis
  • Maintaining up-to-date records of each account and stakeholders within via CRM tool
  • Creating and executing territory business plans that prioritize efforts and resources appropriately
  • Attending conferences where presence offers strategic territorial value
  • Attending procedures in key accounts where presence will enhance selling position

Partner with Burn Clinical Specialist partner to optimize management of all Epicel cases

Develop product advocates for peer-to-peer impact

  • Connecting BTS-CS with stakeholders to develop case studies, white papers, advocates for conferences & Vericel programs, etc.

Expertly leverage promotional materials to effectively tell the Vericel story in a manner that inspires action, including marketing, clinical, and operational information

Work in partnership with BTS-CS (Clinical Support) partner(s) to:

  • Optimize Vericel presence in key accounts and select procedures
  • Leverage their experience to secure introductions to key stakeholders at key accounts
  • Leverage their expertise to help activate dormant and new accounts
  • Advance progress in KOL development

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Basic Qualifications:

  • A professional approach that sees patient welfare as the highest priority, with a strong drive to connect our products and services with every patient who will benefit.
  • 3 to 5+ years of experience of hospital-based specialty healthcare products sales, with a track record of meeting or exceeding sales goals.
  • Experience with hospital operating room environments.
  • Strong background in territory and complex account management with an assertive “hunter” approach
  • Strong clinical and scientific acumen, particularly in burns or wound care.
  • Understanding of medical reimbursement (billing, coding, coverage, and payment) in the healthcare system and ability to work to resolve billing issues with providers.
  • Ability to thrive in a cross-functional team.
  • Bachelor’s or Master’s degree.   Experience with burns or burn nursing a significant plus.

 

Preferred Qualifications:

  • Continuous training on technical and product knowledge.
  • Continuous focus on development of personal and interpersonal skills, such as teamwork, time management, listening, trust and integrity, and work/life balance
  • Strategic agility: ability to align individual business strategy with corporate goals, keen business acumen, problem solving, being innovative and thinking big picture.
  • Drive for results: appropriate resource utilization, focus on fundamentals, utilize established best practices, leverage internal support, and take risks.
  • Professional courage: respectfully challenge physicians, embrace difficult conversations, bring solutions, seek feedback, take accountability and ownership of your actions and results.
  • Managing change: adapt to changing business needs, anticipate questions and challenges, deal with ambiguity, be open and transparent with your customers and your team, integrate into your customers’ practice.

WORKING CONDITIONS AND PHYSICAL DEMANDS

Must manage significant travel demands, including occasional weekend days

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Accounting Manager Finance and Accounting Cambridge OR Ann Arbor 12/14/2021

Vericel, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Finance and Accounting professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet.  Reporting directly into the Associate Controller at Vericel, this individual will also have direct exposure to the CFO and Corporate Controller as part of the Finance leadership team at Vericel.  This is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a strong institutional shareholder base.

The Accounting Manager will be responsible for leading the month end close process and drive accurate and timely financial statements in accordance with U.S. GAAP. In this highly visible role, the Accounting Manager will work cross-functionally with leaders across the company to ensure the close is completed timely and support the business by providing accounting guidance on various initiatives.  The Accounting Manager will oversee accounting issues, streamline process, enhance accounting systems and develop, implement controls enabling them to scale.

ESSENTIAL FUNCTIONS

  • Responsible for the timely and accurate completion of the month end close
  • Review journal entries and account reconciliations
  • Regular review and analysis of balance sheet and income statement accounts
  • Oversee the revenue recognition policies and procedures and ensuring the accuracy of revenue
  • Oversight of the accounts payable team, providing support and leadership
  • Drive the timely completion of the annual audit.  Act as a primary point of contact throughout the audit process for external/internal auditors and consultants
  • Drive continuous process improvement in both the Finance/Accounting teams as well as in the month end close process
  • Oversee accounting issues, streamline process, enhance accounting systems and develop, implement controls enabling them to scale
  • Develop, document and maintain accounting policies, including updating or developing new policies to ensure consistency and compliance with GAAP and other reporting requirements; Provide ongoing training of Company’s accounting policies
  • Recommend and assist in the implementation of process improvements including automation within the ERP and other tools where possible, to simplify, standardize and streamline processes
  • Develop staff by managing performance, setting goals, providing ongoing training, and
    maintaining strong employee relationship
  • Ad hoc projects as needed

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services.  This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

  • 6+ years of experience; CPA required
  • Bachelor’s degree in accounting required; master’s degree in accounting preferred
  • Big 4 or large regional accounting firm experience
  • 3+ years Public company experience
  • Life sciences/Biotech/Medtech experience preferred
  • Expertise and experience in U.S. GAAP, ASC 606 and SOX
  • Experience with Excel, PowerPoint and Word
  • Strategic mindset with ability to manage multiple deliverables and projects
  • Willingness to be into the details
  • Strong written and verbal communication skills

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Associate Director, Payer Contracting Commercial Cambridge 09/20/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Market Access professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Director, Market Access at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

The Associate Director of Payer Contracting will be responsible for leading payer engagement to optimize access and reimbursement. He/she will be responsible for establishing and maintaining connections with public and private payers to ultimately support patient access to innovations from Vericel. This role reports to the Market Access Lead at Vericel

ESSENTIAL FUNCTIONS

  • Strategic aspects:
    • Define an integrated payer strategy to optimize access and reimbursement
    • Maintain and continuously optimize the market access strategy & payer value proposition
    • Identify business growth opportunities within key accounts
  • Operational aspects:
    • Manage relationships with key accounts
    • Oversee all payer relations, including those managed by Specialty Pharmacies
    • Collaborate with internal (e.g., MSL) and external partners, e.g., specialty pharmacies, in implementing payer engagement strategy to optimize access and reimbursement
    • Lead coordinated efforts to deliver value messages of Vericel’s products to payers
    • Support contract strategy and negotiations
    • Work with Market Access and Pricing Analytics to monitor key account pull-through
  • Relationship management
    • Establish and maintain a strong relationship with payer organizations
    • Develop and nurture a strong collaborative partnership with internal cross-functional teams and external vendors
    • Engage with Specialty Pharmacy channel partners for optimization opportunities

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of our products and services. This includes: 

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.

Basic Qualifications:

  • Bachelor’s Degree
  • Minimum of 8 years’ experience in reimbursement / payer marketing / payer contracting in pharmaceutical, medical device, life sciences consulting or the biotech industry
  • Strong strategic thinking and problem-solving skills
  • Strong interpersonal skills
  • A strong sense of responsibility and accountability
  • Excellent communication skills & ability to work effectively with cross-functional teams
  • In-depth knowledge and understanding of the healthcare and reimbursement landscape
  • Experience in payer formulary listing process
  • Well-established stakeholder / influencer network within public and private payer markets
  • Proficient in Microsoft Office and a high level of comfort with data

WORKING CONDITIONS AND PHYSICAL DEMANDS

Occasional business travel to tradeshows, sales meetings, educational programs and customer and partner meetings.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Associate Director, Regulatory Operations Regulatory Cambridge 12/23/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Regulatory professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Senior Director, Regulatory Affairs at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

The Associate Director, Regulatory Operations will manage the operational infrastructure and processes for Vericel products (biologics and devices). They will be responsible for the management of regulatory tracking activities which includes, but is not limited to, submission planning, commitment dates and submission management. This individual will guide the future direction of regulatory technology, systems and associated tools that support Regulatory Affairs. The incumbent will oversee the documentation and submission management processes at Vericel, managing internal and external resources to ensure the compliance with FDA guidelines and other applicable regulatory requirements, which may include those of international regulatory authorities. The individual will report to the Senior Director, Regulatory Affairs and have one direct report. 

ESSENTIAL FUNCTIONS

  • Oversee and maintain the structure of the RIM system (Veeva) to ensure adequate storage, security, and retrieval of regulatory documents. 
  • Ensure FDA requirements for regulatory document retention are met.
  • Work with internal and/or external resources to manage searchable regulatory database that will allow retrieval of regulatory content.
  • Work with internal and/or external resources to manage the submission management processes that will allow document authoring, version control, and links to other documents.
  • Oversees the publishing and electronic submission to FDA and other regulatory agencies.
  • Project manage the planning, tracking and preparation of technically compliant submissions to achieve FDA and Corporate timelines.
  • Works effectively with cross-functional teams in the planning, tracking and preparation of regulatory submission.
  • Contribute to the development of regulatory processes, procedures, and systems to support functional area growth.
  • Work closely with IT business partners on all aspects of regulatory system management.
  • Lead and develop internal regulatory operations staff and manage external vendor relationships.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Education

  • Bachelor's degree (Scientific discipline preferred)
  • Advanced degree (preferred)

Basic Qualifications

  • 10+ years pharmaceutical or biotech industry experience in Regulatory Operations and/or Project Management
  • 8+ years direct Regulatory Operations experience
  • Experience in eCTD submissions and working knowledge of US and international biologics and drug guidelines and regulations related to regulatory operations required.
  • Experience and knowledge in preparation of 510K’s, BLAs, INDs and supportive amendments and supplements.
  • Experience with device submissions, including humanitarian devices and eCOPY.
  • Extensive experience with Microsoft software, authoring templates (ex. StartingPoint), Adobe Acrobat and associated plug-ins required.
  • Strong technical and troubleshooting abilities required.
  • Ability to effectively communicate operational strategy, risk, and methods to interdisciplinary teams.
  • Excellent project management, organizational and communication skills.
  • Ability to work independently as well as part of a team environment.
  • Proven ability to manage multiple projects, identify and resolve regulatory issues.
  • Strong interpersonal skills and the ability to effectively work with others

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Associate General Counsel and Chief Compliance Officer Legal Cambridge 01/11/2022

Vericel Corporation is seeking an experienced and well-rounded attorney to serve as its next Associate General Counsel and Chief Compliance Officer as part of the Company’s growing legal team. The position will report directly to the General Counsel & Corporate Secretary, with dotted line reporting responsibility to the Vericel Board of Directors and will serve a key, senior role in providing advice and counsel on matters that touch all corners of the organization, including corporate governance, securities matters, business development and M&A, and regulatory and market access issues.

As Chief Compliance Officer, the successful candidate will continue to implement and enhance an effective compliance program, serving as the primary individual responsible for continuing to inspire a strong compliance culture at Vericel, assuring employee understanding of their responsibilities and adherence to the Company's Code of Business Conduct and Ethics and related policies and procedures, while providing effective training across the Company. This position will chair the Company's Corporate Compliance Committee and regularly meet with members of the senior management team to evaluate the effectiveness of the Company's ethics and compliance programs and discuss specific compliance matters.

ESSENTIAL FUNCTIONS

  • The Associate General Counsel and Chief Compliance Officer will use his or her understanding of securities law and corporate governance, the biopharmaceutical industry and Vericel Corporation’s business to make meaningful contributions to strategic and operational discussions and provide sound legal advice that advances the Company’s business while protecting the company’s interests.
  • Reporting to the General Counsel & Corporate Secretary, this individual will be responsible for leading or partnering on a broad range of matters, including SEC and Nasdaq compliance, business development initiatives, external communications, intellectual property issues and corporate governance matters.
  • Act as a business partner to senior management and internal constituencies (such as Business Development, Commercial, Finance, Human Resources and Medical Affairs), providing solution-oriented legal advice, risk assessments and interpretations of sophisticated agreements.
  • Help oversee general corporate law functions, including SEC and Nasdaq reporting and compliance, corporate governance, contracting and intellectual property.
  • Partner with cross-functional teams to develop communication strategies and review communication materials, including press releases, scripts, investor relations presentations, medical meeting materials, social media postings, and website content.
  • Work with managed markets to negotiate pricing agreements and manage compliance with government price reporting requirements.
  • Oversee cross-functional efforts to develop and implement policies and procedures and train employees regarding issues related to public company status (e.g., insider trading, individual reporting requirements), contracting requirements, and other matters.
  • Work closely with the General Counsel, Human Resources, Finance and others on matters related to the Board of Directors and its committees, including drafting resolutions and minutes, and attending meetings according to business needs.
  • Partner with senior leadership to maintain and further develop throughout the organization a strong culture of ethics and compliance, including personal accountability at all levels in the organization.
  • Lead an effective Compliance Program, including implementing measures to prevent, detect and correct illegal, unethical, or improper conduct.
  • On a consistent basis, evaluate, and, as necessary, develop and update appropriate policies to ensure compliance with applicable laws, including, specifically, healthcare, patient privacy (e.g., HIPAA), data privacy, transparency, anti-corruption/anti-bribery, antitrust/competition, anti-fraud, and securities laws.
  • Oversee testing and follow-up on matters reported through the Company’s compliance hotline and oversee an effective program for routine monitoring and auditing of adherence to corporate compliance policies and procedures;
  • Identify potential areas of compliance vulnerability and risk, and opportunities for enhanced training, and develop and implement corrective action plans as necessary.
  • Investigate allegations of violations of policy or misconduct; conduct/coordinate investigations; communicate findings to the appropriate senior leadership and Board Committee, as necessary
  • Provide support on all other matters requested by the General Counsel or other members of the Legal/Compliance Department, including with respect to litigation matters, as needed.
  • Supervise external legal counsel on all of the above matters.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as a role model for fellow employees by acting responsibly, fairly, and honestly and exercising sound judgment in performing your job.

Basic Qualifications:

  • J.D. from a law school accredited by the American Bar Association (ABA).
  • Admitted to practice law in one or more states, preferably Massachusetts.
  • 12+ years of experience within a high-growth U.S. publicly-traded biotech, pharmaceutical or technology company, or law firm equivalent.
  • Biopharmaceutical/medical device compliance experience required, ideally with experience relating to commercial operations
  • A successful track record implementing/creating a proactive ethical culture in which compliance and business objectives are mutually reinforcing; strong motivation and ability to champion a comprehensive compliance program that is integrated well with the Company's business planning, operations and culture.
  • Substantive experience in the areas of contract drafting and negotiation, public company reporting and compliance, corporate governance, employment law, litigation, and/or privacy.

Preferred Qualifications:

  • Large law firm experience.
  • Demonstrated leadership and the ability to mentor more junior attorneys.
  • Self-motivated, assertive, and self-confident with the ability to act with urgency and passion.
  • Strong technical/analytical skills, combined with a practical, business-oriented approach to identifying and solving business and legal problems.
  • Entrepreneurial, enjoys working in a fast-paced, small-company environment.
  • Proven ability to work with a high level of integrity, accuracy, and attention to detail.
  • Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete work on-time and on-budget.
  • Excellent oral and written communication skills for effectively interfacing with all levels of the organization.
  • Resourceful, creative, enthusiastic, and results-oriented.

 

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Clinical Account Specialist - Birmingham, AL Sales-MACI Birmingham - Homebased 09/20/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Sales professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Director, Regional Sales at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

Clinical Account Specialist is responsible for MACI sales and Surgeon growth.

ESSENTIAL FUNCTIONS

Core Responsibilities: 

  • Call on orthopedic surgeons and specialists in cartilage repair to deliver a targeted sales message based on accurate clinical information, using approved sales and marketing materials.
  • Attend surgical implantation procedures, as needed, and provide education, training and support to clinical personnel and other staff associated with use and implant of Vericel Products.
  • Ensure completion of Surgeon product training required by FDA.
  • Work with customers to educate on product and procedure reimbursement across different insurance carriers and facilities, and foster a relationship with case management team.
  • Utilize corporate resources i.e. education speaker programs, lunch budgets, and local conference attendance.
  • Knows, understands, and follows Vericel and Government regulations.
  • Territory Borders include Tuscaloosa, Birmingham, Meridian
  • Other projects and assignments as needed.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.

Basic Qualifications:

  • Bachelor’s Degree, with a science, business or marketing degree preferred.
  • 3-5 years of proven successful sales results. OR sales and orthopedic background preferred.
  • Knowledge of anatomy and physiology strongly desired in order to understand where and how products work clinically.
  • Candidate will need to undergo and successfully pass hospital credentialing requirements in order to perform certain aspects of their job, including a 10 panel drug screen.
  • Self-motivated, high commitment and dedication with proactive mindset.
  • Detail oriented with strong analytical and problem-solving skills along with the ability to review voluminous amounts of information (e.g., data tables) and distill relevant information.
  • Ability to develop and manage relationships to meet short, and long-term business objectives.
  • Team player with the ability to lead and build consensus and to work on multiple projects simultaneously.
  • Able to demonstrate flexibility, independence, initiative, creativity, confidentiality, integrity, stability and efficiency.
  • Excellent verbal and written communication, strong presentation and training skills, and interpersonal and relationship building skills.
  • Project management skills and proficiency with Microsoft applications.
  • Ideal candidate will live in Tuscaloosa (AL), Birmingham (AL), Meridian (MS)

WORKING CONDITIONS AND PHYSICAL DEMANDS

Travel minimum 90% of the time within territory. Ability to attend surgery and stand for long periods of time.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Clinical Account Specialist - Grand Rapids Sales-MACI Grand Rapids, MI - Homebased 12/15/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Sales professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Director, Regional Sales at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

Clinical Account Specialist is responsible for MACI sales and Surgeon growth.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Call on orthopedic surgeons and specialists in cartilage repair to deliver a targeted sales message based on accurate clinical information, using approved sales and marketing materials.
  • Attend surgical implantation procedures, as needed, and provide education, training and support to clinical personnel and other staff associated with use and implant of Vericel Products.
  • Ensure completion of Surgeon product training required by FDA.
  • Work with customers to educate on product and procedure reimbursement across different insurance carriers and facilities, and foster a relationship with case management team.
  • Utilize corporate resources i.e. education speaker programs, lunch budgets, and local conference attendance.
  • Knows, understands, and follows Vericel and Government regulations.
  • Territory Borders include South Bend, IN, Ann Arbor and the Upper Peninsula of Michigan.
  • Other projects and assignments as needed.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.

Basic Qualifications:

  • Bachelor’s Degree, with a science, business or marketing degree preferred.
  • 3-5 years of proven successful sales results. OR sales and orthopedic background preferred.
  • Knowledge of anatomy and physiology strongly desired in order to understand where and how products work clinically.
  • Candidate will need to undergo and successfully pass hospital credentialing requirements in order to perform certain aspects of their job, including a 10 panel drug screen.
  • Self-motivated, high commitment and dedication with proactive mindset.
  • Detail oriented with strong analytical and problem-solving skills along with the ability to review voluminous amounts of information (e.g., data tables) and distill relevant information.
  • Ability to develop and manage relationships to meet short, and long-term business objectives.
  • Team player with the ability to lead and build consensus and to work on multiple projects simultaneously.
  • Able to demonstrate flexibility, independence, initiative, creativity, confidentiality, integrity, stability and efficiency.
  • Excellent verbal and written communication, strong presentation and training skills, and interpersonal and relationship building skills.
  • Project management skills and proficiency with Microsoft applications.
  • Ideal candidate will live in Grand Rapids (MI)

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Travel minimum 90% of the time within territory.
  • Ability to attend surgery and stand for long periods of time.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Clinical Account Specialist - Los Angeles West Commercial Los Angeles, CA - Homebased 01/06/2022

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Sales professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Director, Regional Sales at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

Clinical Account Specialist is responsible for MACI sales and Surgeon growth.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Call on orthopedic surgeons and specialists in cartilage repair to deliver a targeted sales message based on accurate clinical information, using approved sales and marketing materials.
  • Attend surgical implantation procedures, as needed, and provide education, training and support to clinical personnel and other staff associated with use and implant of Vericel Products.
  • Ensure completion of Surgeon product training required by FDA.
  • Work with customers to educate on product and procedure reimbursement across different insurance carriers and facilities, and foster a relationship with case management team.
  • Utilize corporate resources i.e. education speaker programs, lunch budgets, and local conference attendance.
  • Knows, understands, and follows Vericel and Government regulations.
  • Other projects and assignments as needed.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:   

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all our products and services.  This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

 

Basic Qualifications:

  • Bachelor’s Degree, with a science, business or marketing degree preferred.
  • 3-5 years of proven successful sales results.  OR sales and orthopedic background preferred.
  • Knowledge of anatomy and physiology strongly desired in order to understand where and how products work clinically.
  • Candidate will need to undergo and successfully pass hospital credentialing requirements in order to perform certain aspects of their job, including a 10 panel drug screen.
  • Self-motivated, high commitment and dedication with proactive mindset.
  • Detail oriented with strong analytical and problem-solving skills along with the ability to review voluminous amounts of information (e.g., data tables) and distill relevant information.
  • Ability to develop and manage relationships to meet short, and long-term business objectives.
  • Team player with the ability to lead and build consensus and to work on multiple projects simultaneously.
  • Able to demonstrate flexibility, independence, initiative, creativity, confidentiality, integrity, stability and efficiency.
  • Excellent verbal and written communication, strong presentation and training skills, and interpersonal and relationship building skills.
  • Project management skills and proficiency with Microsoft applications.
  • Ideal candidate will live in Los Angeles 

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Travel minimum 90% of the time within territory. 
  • Ability to attend surgery and stand for long periods of time.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Clinical Account Specialist - San Diego, CA Sales-MACI San Diego - Homebased 12/15/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Sales professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Director, Regional Sales at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

Clinical Account Specialist is responsible for MACI sales and Surgeon growth.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Call on orthopedic surgeons and specialists in cartilage repair to deliver a targeted sales message based on accurate clinical information, using approved sales and marketing materials.
  • Attend surgical implantation procedures, as needed, and provide education, training and support to clinical personnel and other staff associated with use and implant of Vericel Products.
  • Ensure completion of Surgeon product training required by FDA.
  • Work with customers to educate on product and procedure reimbursement across different insurance carriers and facilities, and foster a relationship with case management team.
  • Utilize corporate resources i.e. education speaker programs, lunch budgets, and local conference attendance.
  • Knows, understands, and follows Vericel and Government regulations.
  • Territory Borders include Greater San Diego area & surrounding counties, south Orange County, Greater Inland Empire, and Military Facilities: Camp Pendleton, Miramar, 29 Palms, and Coronado.
  • Other projects and assignments as needed.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:   

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all our products and services.  This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

 

Basic Qualifications:

  • Bachelor’s Degree, with a science, business or marketing degree preferred.
  • 3-5 years of proven successful sales results.  OR sales and orthopedic background preferred.
  • Knowledge of anatomy and physiology strongly desired in order to understand where and how products work clinically.
  • Candidate will need to undergo and successfully pass hospital credentialing requirements in order to perform certain aspects of their job, including a 10 panel drug screen.
  • Self-motivated, high commitment and dedication with proactive mindset.
  • Detail oriented with strong analytical and problem-solving skills along with the ability to review voluminous amounts of information (e.g., data tables) and distill relevant information.
  • Ability to develop and manage relationships to meet short, and long-term business objectives.
  • Team player with the ability to lead and build consensus and to work on multiple projects simultaneously.
  • Able to demonstrate flexibility, independence, initiative, creativity, confidentiality, integrity, stability and efficiency.
  • Excellent verbal and written communication, strong presentation and training skills, and interpersonal and relationship building skills.
  • Project management skills and proficiency with Microsoft applications.
  • Ideal candidate will live in San Diego 

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Travel minimum 90% of the time within territory. 
  • Ability to attend surgery and stand for long periods of time.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Director of Pharmacovigilance Medical/Clinical Pharma Cambridge 11/22/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Pharmacovigilance professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Chief Medical Officer at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

Core Responsibilities:

  • Provide oversight and guidance for the day-to-day pharmacovigilance (PV) activities of PV partner (CRO)
  • Ensure compliant safety reporting in accordance with local and international reporting regulations and standard operating procedures
  • Collaborate with EU Qualified Person for Pharmacovigilance to update Risk Management Plans (RPMs) and review Pharmacovigilance System Master Files (PSMF)
  • Ensure timely completion of periodic aggregate safety data reports (e.g., PBRER, PADER, DSUR, Annual Device Report, IND annual report), including coordinating internal reviews of these reports
  • Responsible for review and triage of incoming individual case safety reports (ICSRs) and serious adverse events (SAEs) and direct follow-up with reporter as necessary
  • Facilitate internal review of MedWatch/CIOMS reports
  • Review safety database (ARGUS) to ensure accuracy and completeness of data, including review of MedDRA coding consistency
  • Lead development of PV standard operating procedures and work guidelines
  • Serve as the pharmacovigilance subject matter expert for internal audits and FDA inspections
  • Review and update product Safety Management Plans as necessary
  • Facilitate product safety review committee meetings
  • Support due diligence activities and pharmacovigilance partner agreements
  • Participate in signal detection and benefit-risk assessment activities; escalate possible safety concerns
  • Contribute to addressing Health Authority safety queries
  • Oversee medical and scientific literature reviews for published articles relevant to the safety profile of products
  • Provide input and support to the development and updating of safety sections of submission documents, Investigators Brochures, informed consents documents, aggregate safety reports, company core data sheets, product labels, etc.
  • Develop, maintain and provide appropriate PV training for Company personnel
  • Develop and manage annual safety budget

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:   

An ongoing commitment to conducting business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of our products and services.  This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.

Basic Qualifications:

  • Healthcare professional (R.N., B.S.N., Pharm D, M.P.H., MD or equivalent) with a minimum of 7 years of pharmaceutical or biopharmaceutical industry experience
  • Minimum 5 years of relevant U.S. and EU drug safety/PV experience in the biotechnology/pharmaceutical industry
  • Excellent knowledge of FDA, EU and ICH/GCP guidelines and regulations governing post-marketing safety surveillance
  • Experience with safety systems (ARGUS, ARISg or similar systems)
  • Clinical trial research experience
  • Strong analytic and communication skills
  • Demonstrated ability to effectively collaborate with internal colleagues and external partners
  • Preferred: experience working with CROs

 

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Engineering Manager Engineering Cambridge 11/05/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Engineering professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Director, Operations at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

Department Description:

The Engineering department is primarily responsible for the detailed design, startup, troubleshooting, commissioning, optimization and lifecycle support of manufacturing equipment, facilities, and utility systems.

ESSENTIAL FUNCTIONS

Core Responsibilities:

Staff Management:

  • Select, develop, and motivate qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.
  • Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.
  • Coach and mentor staff in all aspect of their job performance and career development including training, feedback, rewards and disciplinary action.
  • Develop work plans, assign tasks, and supervise team(s).
  • Ensure staff has appropriate knowledge of department processes and procedures.

Budget

  • Provide input into the department budget.

Department Management:

  • Establish and report applicable department or organizational metrics.
  • Accountable for project completions and achievement of compliance goals.
  • Represent the Engineering department in project team meetings.
  • Serve as an Engineering department SME where required, including audits, change controls, and deviation investigations.
  • Address and/or escalate site compliance issues
  • Interact with project teams and cross-functional groups.

Additional Responsibilities:

  • Manage corrective, preventative and operation/monitoring programs in a manner ensuring facility personnel safety, continual cGMP compliance, capital investment protection and customer satisfaction.
  • Actively oversee the daily operations and maintenance activities to assure compliance with all company and regulatory agency policies and procedures.
  • Partner with other functional areas to effectively schedule maintenance activities, coordinate resources and assign work to direct reports.
  • Work in a collaborative team environment and interact with other support groups such as Validation, Quality Assurance, Metrology and Scientific groups.
  • Ensure schedule adherence and proper prioritization of workload.
  • Put in place robust operations and maintenance strategy, spare parts inventory and assess areas for continuous improvement.
  • Mentor and develop members of the Engineering group
  • Manage all Engineering projects, ensuring timelines are met
  • Represent the Engineering group during audits

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of our products and services. This includes: 

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.

Basic Qualifications:

  • Bachelor’s degree in Mechanical Engineering, or similar field.
  • A minimum of 7 years of progressively responsible experience in a biotechnology manufacturing environment.
  • Knowledge of cGMP, FDA and other pharmaceutical regulatory requirements.
  • Strong documentation skills of maintenance records in a cGMP environment.
  • Microsoft Office Suite computer systems skills with experience in a computerized maintenance management system.
  • A proven track record of establishing and maintaining cooperative working relationships with internal customers, vendors, and direct reports.

Preferred Qualifications:

  • Proficient in CAD software, preferably AutoCAD.
  • Experience in cGMP record review and regulatory audit participation.
  • Knowledge of facility infrastructure

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Required to work while aseptically gowned in a clean room environment.
  • Work may include working with tools, and some lifting.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
MACI Regional Sales Director - Mid-Atlantic Sales-MACI Mid-Atlantic - Homebased 09/20/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Sales professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Senior Director, Naional Sales - MACI at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

Lead a Sales Culture of Performance through flawless execution of strategy, tactical plans and key initiatives.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Meet or exceed sales goals and achieve results through teamwork and collaboration.
  • Provide leadership in development of selling strategies.
  • Create a high performing organization through recruiting, training, performance management, coaching and mentoring of team.
  • Maximize time in the field with Cell Therapy Specialists to offer continuous and ongoing coaching and development.
  • Build a network of customer and industry contacts for sales development and marketing partnership.
  • Maintain current knowledge of market and competitive trends.
  • Ensure compliance with policies and procedures.
  • Collaborate and partner effectively with peer and support functions.
  • Organize and execute meetings that yield shared insight and result in actionable next steps.
  • Communicate effectively and positively influence the behavior of others.
  • Trust the actions of team members and assume best of intentions with due diligence to verify results
  • Work closely with Cell Therapy Specialists to plan territory coverage and develop customer targeting strategies. Effectively deploy strategies that maximize human and financial resources.
  • Additional responsibilities include: participate in cross-functional strategy sessions, identify market trends through data analysis, proactively work with sales training team to ensure deployment of training to staff, present at Regional and National Sales Meetings, and effectively manage administrative and financial responsibilities

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:   

An ongoing commitment to conducting business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of our products and services.  This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.

Basic Qualifications:

  • The Regional Sales Director position will require that you live in the Mid-Atlantic (East PA down to Virginia) area.
  • Bachelor’s degree in Business or Marketing (preferred)
  • 10+ years of experience in sales in pharmaceutical, biotech or medical device industry.
  • 5+ years of experience directly managing a sales team. Demonstrated career progression within sales, marketing or training. (preferred)
  • Proven track record of consistently meeting or exceeding goals and/or other quantitative targets and qualitative measures.
  • Proven ability to plan, forecast, and manage financial information.
  • Demonstrated experience in creative problem solving, advising management on sales strategy, and motivating team to achieve concrete goals.
  • Excellent verbal and written communication, strong presentation and training skills.
  • Ability to create meaningful relationships with key opinion leaders.
  • Customer focused approach with includes responding to customer and team with a sense of urgency and professional respect.
  • Strong leader with effective coaching and teambuilding skills.
  • Strong understanding of product, disease state and competition
  • Strong knowledge of managed care and product reimbursement of specialty pharmacy/buy & bill.
  • Superior and persuasive negotiation skills required with the fortitude to sell, compete and be a self-starter.
  • Strong working knowledge of MS Outlook, Word, PowerPoint. Working knowledge of MS Excel including basic formulas and formatting.
  • Valid state driver’s license.

Preferred Qualifications:

  • Knowledge of anatomy and physiology strongly desired in order to understand where and how products work clinically (orthopedic background preferred).
  • Self-motivated, high commitment and dedication with proactive mindset.
  • Detail oriented with strong analytical and problem-solving skills along with the ability to review voluminous amounts of information (e.g. data tables) to distill relevant information.
  • Ability to develop and manage relationships in an effort to meet short and long-term business objectives.
  • Team player with the ability to lead and build consensus and to work on multiple projects simultaneously.

WORKING CONDITIONS AND PHYSICAL DEMANDS

Extensive travel required.  Responsible for a large geography. Travel would consist of time spent in field with sales force, attending business meetings, industry meetings and working with key customers.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Manager, Advocacy Development Marketing Boston North - Homebased 12/10/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Director, Advocacy Development at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

The Manager, Advocacy Development will be responsible for identifying educational needs and thought leader engagement strategy among the physician community for clinical conditions specific to the portfolio of Vericel solutions. He/she will source educational content and develop venues for knowledge-sharing. He/she will act as a primary conduit to clinician advocates and educators on behalf of Vericel in three key areas: 1) KOL relationship development and alignment; 2) speaker identification and management and 3) program facilitation and execution. This role reports to the Director, Advocacy Development.   

ESSENTIAL FUNCTIONS

Relationship management:

  • Identify, cultivate and engage healthcare professionals with expertise in specific clinical conditions
  • Source educational content
  • Nurture relationships with and develop utilization plans for key opinion leaders
  • Facilitate a recurring advisory board of healthcare professionals
  • Speaker bureau management and speaker training
  • Work with Marketing, Sales leadership, and contracted speakers/consultants to gain feedback in support of the evolution of promotional programming content
  • Support internal colleagues & field-based members of the commercial team
  • Guide the contribution of agency partners

Strategy development:

  • Identify and prioritize gaps in knowledge among healthcare professionals in specific clinical conditions
  • Curate presentation content for educational & promotional events
  • Attend and aid in the coordination of conferences and scientific meetings as identified and directed
  • Collaborate with cross-functional colleagues to enhance advocacy of Vericel portfolio
  • Contribute to the allocation and management of budget expenses

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services.  This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

Experience collaborating with health care professionals in order to develop clinical educational programs.

  • Bachelor’s degree (Advanced degree in healthcare, education -related field is preferred)
  • Minimum of 3 years’ experience in the healthcare and/or life sciences field
  • Strong interpersonal & relationship -building skills
  • Demonstrable success managing projects
  • Excellent communication & organizational skills
  • Strategic, passionate, self-starter who takes initiative
  • Availability to travel
  • Responsibilities may require a work schedule that may include working outside of “normal” work hours in order to meet business demands
  • Proficient in Microsoft Office

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Travel up to 50%

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Manufacturing Technician Manufacturing Cambridge 11/24/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Manufacturing professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Senior Manager, Manufacturing at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

Department Description:

Manufacturing of cell therapy products.

 

Position Summary:

Responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.

 

Core Responsibilities:

  • Perform manufacturing procedures inside an ISO Class 7 clean room in accordance to established SOPs, cGMPs, and safety regulations.
  • Perform aseptic manipulations of cell culture lots and final product assemblies.
  • Document production operations in corresponding batch records and log sheets according to cGMPs and established SOPs.
  • Input data from production records to existing databases.
  • General housekeeping of manufacturing controlled areas.
  • Perform clean room equipment sanitization.
  • Record equipment metrology readings to ensure the equipment operates within specifications.
  • Interact with other departments such as Engineering, Facilities, Materials Management, QA, QC, R&D, Training, and Validation.
  • Review completed production records for accuracy.
  • Work independently under general supervision and direction.
  • Organizational and planning skills and the ability to cooperate with others in a team environment will be critical to success.
  • Practice safe work habits and adhere to Vericel’s safety procedures and guidelines. Other duties as assigned.

 

Leadership Qualifications:

An ongoing commitment to conducting business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.

Basic Qualifications:

  • Biotechnology certificate or equivalent with 0-2 years of experience working in a cGMP environment in the biotechnology or pharmaceutical industry, or 3+ years of cGMP experience with GED or equivalent.
  • Excellent communication skills, written and verbal.
  • Organizational and planning skills and the ability to cooperate with others in a team environment.
  • Experience with Microsoft Office.

 

Preferred Qualifications:

  • Experience working in an ISO 7 clean room environment.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • May be required to sit for long periods of time while performing cell culture operations.
  • Must be able to lift, carry, push and pull up to 50 lbs.
  • Ability to work 1 weekend day.
  • Rotating holiday coverage.
  • Ability to gown and gain entry to manufacturing areas.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Materials Associate MFG Support Services Cambridge 12/02/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing  professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Supervisor, Materials at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

Department Description:

Responsible for maintaining an uninterrupted supply of materials for the manufacture of cell therapy products.  

Position Summary:

Responsible for the stocking of materials to support the manufacture of commercial cell therapy products meeting internal and regulatory requirements.

ESSENTIAL FUNCTIONS

  • Master core responsibilities of a Materials Technician (Handler).
  • Receive and distribute all Quality Controlled inspected and non-Quality Control inventoried material and general goods received at the Vericel site.
  • Independently perform material receipt and shipment.
  • Execute transactions in Microsoft Dynamics Great Plains (GP) ERP (enterprise resource planning) system independently or with supervision.
  • Maintains inventory control in ERP system by performing system transactions at time of material receipt, storage and distribution.
  • Completes material In-Transit Requests within ERP system for material deliveries from Third Party off-site storage location(s).
  • Assist in preparation of inventory sales order fulfillment process and end of day closing activities.
  • Perform material labeling activities supporting Manufacturing Execution Systems (MES); also referred to as EBR (electronic batch record(s)).
  • Performs routine inventory cycle counts including media. 
  • Participates in scheduled annual physical inventory activities. 
  • May interact with various groups (e.g., Customer Care, Facilities & Engineering, Finance, Manufacturing, Quality Operations, R&D, and third-party logistics providers (3PL)) on material requests and receipt transactions.
  • Maintenance of material staging area.
  • May assist in providing on the job training to employees.
  • May be assigned on-call responsibility.
  • Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.

Basic Qualifications:

  • GED, High school diploma or equivalent with 2 - 5 years of experience working in a cGMP environment in the biotech or pharmaceutical industry or equivalent.
  • Familiarity with MS Office.

Preferred Qualifications:

  • Experience in high volume and fast-paced materials and cleanroom environment.
  • Experience working in warehouse environments.
  • Experience within a regulated environment that is frequently audited by FDA, ISO and other internal and external Agencies.
  • Excellent communication skills, written and verbal.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Ability to gown and gain entry to manufacturing areas.
  • May be required to stand for long periods of time while performing physical duties.
  • Must be able to lift, carry, push and pull up to 50 lbs.
  • Ability to work 1 weekend day.
  • Rotating holiday coverage.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Production Scheduler Manufacturing Cambridge 08/02/2021

POSITION SUMMARY

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Production Scheduler professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Manager, MACI Manufacturing at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

Department Description:

Manufacturing of cell therapy products.

Position Summary:

Responsible for creation and maintenance of the master manufacturing production work schedule which includes the manufacture of commercial cell therapy products.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Create, confirm and maintain manufacturing production schedule for multiple product lines using the Preactor scheduling software program.
  • Assess customer orders, available staff, equipment and cellular inventory to effectively set and simultaneously manage production schedules for multiple product lines.
  • Plan daily, weekly and monthly manufacturing schedules and the associated resource allocation.
  • Constantly monitor, assess and when necessary provide recommendations to improve the effectiveness and functionality of the scheduling software (e.g., beneficial reports, updates for new activities, etc.).
  • Support and participate in scheduling related projects and key initiatives that directly support the Manufacturing department, including resource planning of labor, materials and equipment.
  • Perform sales order support using the ERP, scheduling and CRM systems.
  • May provide support for inventory management and control within ERP and MES systems.
  • Serve as a liaison between Manufacturing and Customer Care.
  • Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.

Basic Qualifications:

  • Bachelor’s or higher degree and 4+ years of experience with manufacturing operations scheduling.
  • Associate degree and 6+ years of experience with manufacturing operations scheduling, or 8+ years of scheduling experience with GED or equivalent.
  • Excellent communication skills, written and verbal.
  • Advanced to expert level ability with Microsoft office.
  • Experience with ERP, MES, CRM and scheduling systems (e.g., Microsoft Dynamics GP, MFG/Pro, SAP, Preactor, etc.).

Preferred Qualifications:

  • Experience in cGMP production environments.
  • Experience working within a regulated environment that is frequently audited by internal and external Agencies, such as the FDA and ISO.
  • Proven analytical, problem solving and facilitation skills

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • May be required to sit for long periods of time while performing physical duties.
  • May be required to provide weekend coverage.
  • Monday - Friday schedule 12:30pm-9:00pm
  • Rotating holiday coverage.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Quality Assurance Specialist I Quality Assurance Cambridge 11/24/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Quality Assurance professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Manager, Quality Operations at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

Department Description:

The Quality Assurance department ensures that the site operates at a high level of compliance and ensures quality decisions are being made in accordance with regulatory and site requirements.

Position Summary:

This position is responsible for operational support, including batch record review, media disposition, label issuance and reconciliation, archiving and final product packaging/release to the courier.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Responsible for batch record documentation and for final batch disposition
  • Support day to day operations, including: batch record and label issuance, archiving and verification
  • Review and approve product and process deviations.
  • Follow oral and written procedures for review and release of intermediate and final product.
  • Participate in audits to ensure compliance to cGMPs and Vericel requirements.
  • Identifies deficiencies and works with internal departments to remedy them.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.

Basic Qualifications:

  • Bachelor's Degree in related field. Biotechnology certification will also be considered. 

Preferred Qualifications:

  • 1 year of GMP experience 
  • Strong written and verbal communication skills.
  • Strong organization and time management skills.
  • Proficient in MS Office suite.
  • Experience in a biotech, pharmaceutical or other regulated industry.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Ability to lift and transport up to 30 lbs.
  • Ability to work 1 weekend day.
  • Rotating holiday coverage.

 

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Quality Assurance Specialist II Quality Assurance Cambridge 11/24/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Quality Assurance professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Manager, Quality Operations at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

Department Description:

The Quality Assurance department ensures that the site operates at a high level of compliance and ensures quality decisions are being made in accordance with regulatory and site requirements.

Position Summary:

This position is responsible for operational support, including batch record review, media disposition, label issuance and reconciliation, archiving, final product packaging/release to the courier, customer complaint audits, write and/or revise standard operating procedures

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Master core responsibilities of Specialist I.
  • Maintaining and adhering to compliance requirements for established quality systems programs.
  • Identify issues, provide recommendations as well as executing compliance improvements.
  • Participate in mid-scale projects or assignments.
  • Address and/or escalate compliance problems and issues.
  • Interact with project teams and applicable research groups as they impact the quality operation.
  • Product complaints: independently receive, review, audit accompanying patient file, and send to Customer Care.
  • Independently initiate QA deviations and perform investigations, including determining root cause and planning corrective actions.
  • Support the training of specialist I’s.
  • Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.

Basic Qualifications:

  • Bachelor's Degree plus 3+ years of related experience in Quality Assurance.
  • Basic knowledge of GMP regulations

Preferred Qualifications:

  • Strong written and verbal communication skills
  • Strong organization and time management skills
  • Experience with Electronic Quality Management Systems (Trackwise)
  • Proficient in MS Word, Excel, and PowerPoint

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Ability to lift and transport up to 30 lbs
  • Ability to work 1 weekend day (Schedule: Sunday-Thursday)
  • Rotating holiday coverage.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Quality Control Analyst, Senior Quality Control Cambridge 11/24/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Quality Control professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Senior Manager, QC Microbiology at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

Department Description:

Quality Control (QC) is responsible for incoming inspection of components and raw materials, plus quality testing (e.g. analytical, microbiological) of intermediate, stability and final product samples to demonstrate that all products manufactured meet standards required for cGMP operations. Various techniques (e.g. assay transfers, validation and qualification of new instrumentation) are utilized within the Quality Control Laboratory to ensure cGMP compliance.

Position Summary:

Responsible for performing routine and complex testing of in-process samples and final products in accordance with SOPs for product release and validation.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Perform QC testing in a cGMP lab for raw material release, final product/in process testing and process qualifications
  • Conduct data analysis of testing results, and review data obtained for compliance to SOP and specification.
  • May transfer methodology from other groups and may maintain complex equipment.
  • Author reports, SOPs and other documentation for quality testing.
  • Provide training and technical leadership to less experienced staff.
  • Participate in and/or perform laboratory investigations and non-conformance deviations.
  • Perform finished product review and lot release.
  • Manage departmental projects.
  • Serve as the laboratory point of contact for less experienced staff when management is not present (weekends, holidays)
  • Participate in the execution of corrective and preventative action plans as well as the initiation and follow through for change controls.
  • Author protocols and technical reports related to the implementation of QC equipment.
  • Master core responsibilities of an Analyst II.
  • Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make the company a great place to work, and a company respected for the quality of its people and products.

Basic Qualifications:

  • Bachelor's Degree or equivalent and 4 +years of experience in a lab setting.

Preferred Qualifications:

  • Experience as a technical leader in a strong team environment and work independently to successfully balance short and long term project objectives.
  • Experience with Deviation Management and Change Control.
  • Experience with complex analytical methods such as PCR based methodology or cell culture methods.
  • Experience with assay/equipment validations/transfers.
  • Experience with microbiological testing or environmental monitoring.
  • Excellent communication skills, verbal and non-verbal desired.
  • Excellent technical writing and investigational skills.
  • Advanced microbiological techniques, disinfectant efficacy, microbial identification, rapid methods, etc.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Ability to lift 40 lbs.
  • Requires working one day per weekend.
  • Rotating holiday coverage.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Quality Control Supervisor Quality Control Cambridge 11/15/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Quality Control professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Senior Manager, QC Microbiology at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

Department Description: Quality Control (QC) is responsible for incoming inspection of components and raw materials, plus quality testing (e.g. analytical, microbiological) of intermediate, stability and final product samples to demonstrate that all products manufactured meet standards required for cGMP operations. Various techniques (e.g. assay transfers, validation, and qualification of new instrumentation) are utilized within the Quality Control laboratories to ensure cGMP compliance.

Position Summary: This position is responsible for overseeing operations within the QC laboratory. This position is also responsible for hiring, training, supervising, developing and performance planning of staff and will provide day to day direction for direct reports. This motivated and organized individual with strong people skills will provide supervision and technical expertise to the QC laboratory while maintaining open communication channels to meet the needs of the organization.

Leadership Qualifications:

An ongoing commitment to conducting business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.

Basic Qualifications:

  • Bachelor’s degree or equivalent and 8+ years of experience in a lab setting, or Master’s degree or equivalent and 6+ years’ experience in a lab setting.
  • Proficient in Microsoft Office and lab based data management systems.
  • Ability to present technical data.
  • Ability to coordinate testing expectations across Lot Release, QC Microbiology and Raw Material Testing.
  • Experience in a lead or Supervisory role.
  • Experience troubleshooting and investigating assay and equipment issues.
  • Experience with identifying root cause.

Preferred Qualifications:

  • Experience facilitating meetings.
  • Familiarity with Deviation Management Systems (i.e. Trackwise).

Working Conditions and Physical Demands:

  • Ability to work 4 day, 10 hour schedule (Friday – Monday, 7 AM – 5 PM).
  • Ability to lift 40 lbs.
  • Rotating holiday coverage

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Quality Systems Engineer I Quality Assurance Cambridge 11/24/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Engineering professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Vice President, Quality at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

Department Description:

The Quality Systems Department manages Change Control, Product Quality Reviews, Management Reviews and Risk Management. QS ensures compliance with company procedures and industry standards in support of cell therapies products. Staff works closely with subject matter experts to facilitate the development and rapid adoption of value-added changes and processes, ensuring implementation is compliant with regulations, procedures and policies.

Position Summary:

This individual will assist in ensuring that quality systems are in place and cGMP compliance is maintained. Work and decisions will be based on a collaborative culture with Manufacturing, Engineering, Facilities and Validations.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Support revision of procedures as required to ensure that documentation and operations meet established requirements of regulations, cGMPs, and internal SOPs and company policies.
  • Apply and maintain quality standards and procedures for quality systems.
  • Review executed cGMP documents and participate in the implementation of systems for the acquisition, processing and storage of cGMP information.
  • Monitor the status of assigned quality system(s), providing periodic reports and status updates on the overall performance of the quality system(s).

Key Functions may be in support of one or more of the following:

Change Control/Design Control:

  • Support the process of change control approval from evaluation of an initial proposal through approval, implementation, closure and effectiveness review.
  • Provide QA support of change controls to ensure that they meet the requirements of Vericel standards and procedures, and are clearly written and appropriately justified. Provide QA approval of those changes at various points in the change life cycle, utilizing a quality management system electronic workflow.
  • Apply and interpret Vericel procedures governing the change control process to proposed changes, consulting with QA management as appropriate. Work with project teams to determine the change control approach for projects.
  • Verify the completeness and correctness of supporting documentation for changes, including items such as engineering studies, validation protocols, technical reports, engineering drawings and SOP changes.
  • Assist in the management of the Design Control program, updates to Design History Files, and participate as a Quality representative in the design review process.
  • Monitor the status of open changes, providing periodic reports and status updates on the overall performance of the change control system.

Risk Management:

  • Assist with driving activities of the risk management program with respect to scheduling meetings, developing quality documentation and data management.
  • Help ensure that manufacturing sites comply with the requirements of the risk management program and complete assessments and reports in a timely manner according to regulations, procedures and policies.
  • Participate in the risk assessment process as it relates to assisting with categorizing risk and assigning report numbers.
  • Provide clear and concise reports of risk management activities/ assignments throughout the site and provide key metrics that monitor compliance for the risk management program.
  • Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:   

An ongoing commitment to conducting business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.

Basic Qualifications:

  • Bachelor’s degree or equivalent with 1+ years of cGMP experience.
  • Prior experience working in a Quality/Compliance role within the pharmaceutical or medical device industry.
  • Experience writing and reviewing technical cGMP documents.
  • Experience with an electronic Quality/Document Management System.
  • Strong written and verbal communication.
  • Experience operating in an environment with strict timelines.

Preferred Qualifications:

  • Advanced proficiency in basic Microsoft Office applications: Word, Excel, PowerPoint
  • Familiarity with advanced Microsoft Office applications: Visio, Project, Access.
  • A strong understanding of Medical Device and Biologics FDA regulations.
  • Strong working knowledge of quality management systems.
  • Proven Risk Management/FMEA experience/knowledge.
  • Good project management skills and working knowledge of statistical techniques.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Occasional overtime may be required in support of site inspections.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Scientist II Research and Development Cambridge 11/24/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing R&D Scientist professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Director of R&D at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

Department Description:

The Research and Development group within Vericel supports the continuing development, characterization and validation of manufacturing methods, novel assays, new technology and operational improvements. This group manages technology transfers, clinical manufacturing, training, database development, trending analysis and stability. The R&D team plays an important role in commercial manufacturing troubleshooting, root cause investigation, process optimization and product life cycle management.

Position Summary:

Applies scientific and/or engineering principles and expertise in the design and development of robust, cost-effective manufacturing procedures and associated analytical method that meet quality, GMP, regulatory and health, safety, and environmental standards.

Core Responsibilities:

  • Demonstrates a comprehensive solid understanding and use of scientific / engineering principles and professional practices, to solve a wide range of complex problems in creative and practical ways.
  • Leads design reviews, cross-functional development teams and provides scientific / engineering support and guidance in the development, scale-up, optimization and operation of methods for the production and testing of new components, technologies and products.
  • Maintains and demonstrates significant knowledge of state-of-the art principles and theories in area of responsibility.
  • Independently reviews existing process and analytical development and production data; designs and conducts necessary experiments; interprets results; recommends changes or additional experiments.
  • Designs, executes, and interprets experiments to identify new methods to enhance the manufacture of or characterization of products in regard to safety, identity, strength, purity, stability and quality with minimal direction.
  • Stay abreast of new developments/technologies in areas of responsibility. Prepares proposals for introduction of technologies outlining the positive impact to the product for cost and/or quality.
  • Participate in establishing project strategy in consultation with management.
  • Represents the corporation in the greater biotech community by publishing in peer review journals and participation in scientific / technical conferences.
  • Represents the organization as the prime technical contact on contracts and projects. Interacts with senior external personnel on significant technical matters often requiring coordination between organizations.
  • Guides the successful completion of major programs and may function in a project leadership role.
  • Directs the work of more junior staff. Provides technical guidance and trains less experienced staff.
  • Other duties as assigned.

Leadership Qualifications:

An ongoing commitment to conducting business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.

Basic Qualifications:

  • BS and 9+ years of related work experience, or
  • MS and 7+ years of related work experience, or
  • Ph.D. or equivalent in Biology, Biochemistry, Biomedical, Chemical, or Mechanical Engineering, or related fields and 4+ years of related work experience.
  • Expertise in one or more of the following: Bioengineering, Molecular Biology, Flow Cytometry.
  • Advanced expertise in mammalian cell culture and related techniques.
  • Proficient with technical writing and statistical analysis to produce technical and/or validation protocols and reports.

Preferred Qualifications:

  • 4+ years of experience working on development or support of assays and/or manufacturing processes for a biological drug in a GMP facility.
  • 4+ years of experience in isolation and culturing human primary cells.
  • 4+ years of experience in developing autologous cell therapies or tissue engineered products.
  • Hands-on analytical experience using techniques such as RNA/DNA purification, PCR, qPCR, multi-color flow cytometry, cell counting, and cell-based assays.
  • Experience designing primers and probes for qPCR and gene expression analysis.
  • Advanced expertise in product, process and test method development as well as mechanical design, prototyping, biomaterials.
  • Technical ability to turn design ideas into product/process improvements.
  • Proficient in CAD software, preferably AutoCAD and MATLAB
  • Good leadership and people skills, teamwork experience, and demonstrated conflict handling and resolution ability and negotiation skills.
  • Good achievement and record in scientific research and technical development as evidenced by research paper, conference presentation, and patent publications.
  • Self-motivated, organized, familiar with the relevant literature, attention to details.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Senior Accountant Finance and Accounting Cambridge OR Ann Arbor 12/14/2021

Vericel, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Finance and Accounting professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet.  Reporting directly into the Assistant Controller at Vericel, this individual will also have direct exposure to the Finance leadership team and collaborate with various functional leaders at Vericel.  This is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a strong institutional shareholder base.

The Senior Accountant will be responsible for execution of cost accounting functions, reporting of actual results to management, and assisting in the fiscal planning and forecasting of consolidated COGS accounts.  The Senior Accountant will also be responsible for other areas in the close process including overseeing fixed assets.

ESSENTIAL FUNCTIONS

  • Analyze current cost accounting processes including inventory management, mapping processes and provide recommendations for future process changes
  • Analyze inventory transactions to ensure that all are appropriately recorded in sub-ledgers and general ledger. Includes the monthly recording of inventory reserve adjustments.
  • Complete account analyses and monthly balance sheet reconciliations for areas of responsibility
  • Contribute to monthly corporate forecasting and annual budgeting with emphasis on gross margin and working capital requirements
  • Manage inventory accuracy at offsite warehouse locations storing finished goods and raw materials
  • Maintain standard costs across all inventory items
  • Oversee inventory variance accounting, including purchase price variances, manufacturing variances and revaluation to ensure accurate accounting of such variances
  • Integrate with the Manufacturing and Supply Chain teams and establish yourself as a valued business partner
  • Prepare related audit schedules and other requests from internal/external auditors and partners
  • Educate management on the inventory process
  • Responsible for the timely and accurate completion of month end close tasks including journal entries and account reconciliations
  • Drive continuous process improvement in the inventory and cogs areas
  • Recommend and assist in the implementation of process improvements including automation within the ERP and other tools where possible, to simplify, standardize and streamline processes
  • Oversee SOX controls in inventory
  • Fixed asset management including reviewing depreciation, additions, etc.
  • Ad hoc projects as needed

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services.  This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

  • 4-5+ years of experience; CPA preferred
  • Bachelor’s degree in accounting required
  • Big 4 or large regional accounting firm experience preferred
  • 2+ years Public company experience
  • Manufacturing experience, preferably in Life sciences/Biotech/Medtech
  • Experience with Excel, PowerPoint and Word
  • Strong willingness to be into the details and learn how transactions flow through the ERP
  • Strong written and verbal communication skills

 

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Senior Manager, External Reporting Finance and Accounting Cambridge OR Ann Arbor 12/14/2021

Vericel, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Finance and Accounting professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet.  Reporting directly into the Assistant Controller at Vericel, this individual will also have direct exposure to the CFO and Corporate Controller as part of the Finance leadership team at Vericel.  This is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a strong institutional shareholder base.

The Senior Manager, External Reporting will be responsible for leading the SEC reporting and oversee various technical accounting areas such as stock-based compensation, leases and investments. This individual will work closely with the Assistant Controller and Corporate Controller to ensure all SEC filings are filed accurately and timely.  In this highly visible role, the Senior Manager, External Reporting will work cross-functionally with leaders across the company to support, maintain and enhance our SEC reporting and support the business by providing technical accounting guidance on various initiatives.  Additionally, the Senior Manager, External Reporting will partner with the Assistant Controller, Controller and other leaders on strategic projects, including evaluating potential business development and other potential strategic and financing transactions and concluding on the technical accounting implications.

ESSENTIAL FUNCTIONS

  • Manage and execute the SEC filings including the 10-K, 10-Q’s and support the annual Proxy
  • Collaborate with IR and Legal on various SEC reporting matters
  • Participate in quarterly earnings process, including review of earnings release and earnings call script and presentations
  • Oversee the preparation of the consolidation including the preparation of the balance sheet, income statement and cash flow statements
  • Manage lease accounting activities
  • Oversee stock-based compensation expense and accounting around stock options, RSUs and other equity related matters
  • Oversee any investment accounting activities
  • Work closely with external auditors to drive timely accounting conclusions and disclosures. Act as a primary point of contact throughout the audit process for external/internal auditors and consultants on technical matters and financial reporting
  • Drive continuous process improvement in both the Finance/Accounting teams as well as in external reporting process
  • Research application of accounting standards, determine potential effects to Vericel of new accounting standards and effectively communicate the impact to stakeholders throughout the company, including Senior Management
  • Research various technical accounting matters, conclude on the proper U.S. GAAP treatment, document technical accounting memos and present to Senior Management and/or external auditors as needed.
  • Develop, document and maintain accounting policies, including updating or developing new policies to ensure consistency and compliance with GAAP and other reporting requirements; Provide ongoing training of Company’s accounting policies
  • Recommend and assist in the implementation of process improvements including automation within the ERP and other tools where possible, to simplify, standardize and streamline processes
  • Manage, train and develop team members
  • Ad hoc projects as needed

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services.  This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

  • 7+ years of experience; CPA required
  • Bachelor’s degree in accounting required; master’s degree in accounting preferred
  • Big 4 or large regional accounting firm experience
  • 3+ years Public company experience
  • Life sciences/Biotech/Medtech experience preferred
  • Expertise and experience in U.S. GAAP, ASC 606 and 842 and SOX
  • Experience with Excel, PowerPoint and Word
  • Experience with financial reporting tools such as Workiva and Adaptive Insights
  • Strategic mindset with ability to manage multiple deliverables and projects
  • Willingness to be into the details
  • Strong written and verbal communication skills

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Senior Manager, Regulatory Affairs Regulatory Cambridge 12/23/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Regulatory professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Director, Regulatory Affairs at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

The Senior Manager, Regulatory Affairs manages, evaluates and completes regulatory projects consistent with the company goals. Responsible for timely planning and coordination of regulatory submissions. Provides guidance to cross-functional teams on regulatory strategy and tactics. Keeps abreast of regulatory procedures and practices. The incumbent will work independently with appropriate oversight and is expected to identify and act on activities without requiring immediate direction.

ESSENTIAL FUNCTIONS

  • With minimal supervision, plan and manage regulatory activities related to assigned development projects. Assist in developing and implementing strategies for the earliest possible approvals of regulatory submissions associated with assigned development projects.
  • Manage the assembly and timely submission of 510Ks, INDs, BLAs and other dossiers as required for investigation and registration of drugs, biologics and devices in the US.
  • Ensure regulatory submissions are maintained in compliance with regulatory requirements.
  • Represent the company in its dealings with the FDA and other regulatory authorities, as appropriate.
  • Participate on project teams and provide expertise on regulatory matters.
  • Develop and maintain current regulatory knowledge and advise management of significant developments.
  • Contribute to improvements in department best practices and SOPs.
  • Perform other duties as required, interfacing with other departments, CROs, and external vendors as needed.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Education

  • Bachelor of Science in a scientific discipline.
  • Master of Science (preferred)

Basic Qualifications

  • 5+ years direct Regulatory Affairs experience in the US market.
  • Experience with drugs, biologics and medical devices.  Previous experience with combination products and/or botanicals a plus.
  • Experience and knowledge in preparation of 510K’s, BLAs, INDs and supportive amendments and supplements.
  • Experience with prescription drug advertising regulations and promotional review committee’s
  • Experience with labeling and UDI regulations
  • Working knowledge of FDA regulations and understanding of FDA structure and function.
  • Working knowledge of eCTD elements and structure.
  • Strong regulatory writing skills and use of Microsoft Word.
  • Strong team player that has a customer service approach and is solution oriented.
  • Attention to detail and the ability to work individually, within a multidisciplinary team, or with external partners and vendors.
  • Possess excellent written and verbal communication skills.

WORKING CONDITIONS AND PHYSICAL DEMANDS

Occasional travel (5-10%)

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Training Specialist Quality Assurance Cambridge 11/24/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing training professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Senior Director, Corporate Information System at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

Department Description:

This department manages the Vericel training system. They develop, manage, and support training programs within the company to meet GxP regulations, internal processes and standards, and to develop the skill set of all employees.

Position Summary:

Responsible for the design, maintenance, and administration of the training Learning Management System (primarily electronic with some paper-based elements). This position is responsible for establishing and implementing the strategy for maintaining training requirements and curricula by ensuring training documentation is completed, processed, filed, and archived in accordance with GxP and Vericel standards. May deliver specific GxP, New Hire Orientation and other related training material as needed.

ESSENTIAL FUNCTIONS

Serve as Training Learning Management System Administrator by establishing, managing, and continually improving strategy for GxP compliance (35%):

  • Manage the LMS system (ComplianceWire).
  • Provide training system and LMS support to functional areas and Training personnel.
  • Represent training department during internal and external regulatory audits and provide LMS support as necessary.
  • Develop, maintain, and provide training on Vericel LMS to applicable personnel.
  • Maintain process for training record data entry, filing, archival, and retrieval.
  • Actively research and analyze industry learning technology trends and determine applicability to the Vericel training system.
  • Other duties as assigned.

Provide Training LMS and Logistical Support (30%):

  • Act as an LMS coordinator and provide LMS reports as necessary.
  • Process training data (training records, curricula updates) in the LMS in a timely fashion and file accordingly.
  • Address general training system and LMS inquiries, including (but not limited to): confirming training status, process for establishing/editing curricula, prerequisite requirements for training, etc.
  • Assist with delivery/training setup for SMEs delivering training (WebEx, presentations, etc.).
  • Coordinate with New Hire Orientation stakeholders and schedule personnel for new employee training.
  • Work with owning departments and qualified trainers to schedule instructor-led training sessions.
  • On occasion, assist functional areas with scheduling personnel for the appropriate qualifications such as gowning, aseptic technique, foreign matter, etc.

Develop and deliver training programs, as needed (15%):

  • Work with the training team and collaborate with functional area management and SMEs to design, develop, approve, and maintain training curricula and training materials in a GxP environment.
  • Partner with document authors and process owners to establish training approach for functional area procedures and processes by performing needs analysis.
  • Evaluate existing training programs and improves training solutions, where applicable.
  • Exercise sound judgment in determining method of trainee evaluation and qualification on specific tasks or activities.

Establish, maintain, and generate site training metrics and LMS reports focusing on agreed upon KPIs (10%):

  • Work with senior leadership and functional area management to establish Key Performance Indicators for the training system.
  • Generate and present/provide training metrics as needed.
  • Partner with functional areas to address identified training compliance gaps.

Partner w/functional areas to conduct training effectiveness checks and trending of results (10%):

  • Establish mechanism for assessing the effectiveness of training programs (ILT, OJT, E-Learning) using Kirkpatrick's Levels of Evaluation.
  • Track and trend effectiveness of programs, and work with other Training Department personnel to provide recommendation to area management to improve training programs.
  • Manage course evaluations and other training effectives tools.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.

Required Education and Experience:

  • Bachelor’s degree and 3+ years relevant experience in a GxP Training environment involving the maintenance of a Learning Management System.
  • Prior Learning Management System experience with an emphasis on design and maintenance. Familiarity of ComplianceWire LMS preferred.
  • Must be customer-focused and service-oriented with effective communication skills.
  • Works independently and efficiently with minimal supervision/guidance.
  • Proficient with Microsoft Word, Excel, Visio.
  • Organizational and time management skills, ability to multi-task while still meeting deliverables.
  • Project management skills with an ability to take on leadership roles.
  • Technical writing experience (i.e. development of SOP and/or OJTs).

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • May be required to work in classified and controlled areas such as clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Validation Director Quality Assurance Cambridge 11/24/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Validation professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Vice President, Quality at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.POSITION SUMMARY

Department Description:

The Validation Department provides documented evidence that Operational equipment, systems, and processes involved in commercial product manufacturing, perform in a qualified and reproducible manner, and comply with regulatory compliance requirements and current industry/Vericel policy and guidance. The deliverables of the Validation Department include approved Validation protocols and Final Reports. The department also functions as the liaison with Metrology/Calibration Vendors and performs all equipment ownership and quality review responsibilities associated with site calibration activities.

Position Summary:

This position is responsible for the oversight and management of the deliverables of the Validation Department which includes supporting validation for computer systems, equipment, utilities, cleaning, sterilization, and processes and equipment requalification. This position directs the development, planning, implementation and maintenance of validation methods, processes, and operations. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.  Oversees department schedules, ensuring compliance with appropriate regulatory agency requirements, internal company policies and current industry practices. 

ESSENTIAL FUNCTIONS

Staff Management:

  • Select, develop, and motivate qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.
  • Provide career development and guidance to direct reports. Identify training requirements/needs and job-related qualifications.
  • Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.
  • Coach and mentor staff in all aspect of their job performance and career development including training, feedback, rewards, and disciplinary action.
  • Develop work plans, assign tasks, and supervise team(s).
  • Ensure staff has appropriate knowledge of department processes and procedures.

Budget:

  • Provide input into budget forecasting when appropriate.

Department Management:

  • Establish, maintain, and report applicable department or organizational metrics which drive accountability.
  • Accountable for project completions and achievement of compliance goals relative to deviations, change controls, CAPA and effectiveness reviews.
  • Represent department in Project Team meetings.
  • Interact with project teams and cross-functional groups.
  • Address and/or escalate site compliance problems and issues to senior department management.
  • Lead and facilitate meetings/workshops.
  • Participate in the integration of new computer systems and processes.
  • Responsible for always keeping the department in audit ready condition.

Additional Responsibilities:

  • Ensure compliance with appropriate internal and regulatory policies and procedures.  
  • Responsible for the creation of validation master plans, and integrated commissioning and qualification plans. Reviewing and approving commissioning and validation documents in accordance with current GMPs.
  • Determine and develop validation approaches and resolve complex validation issues, working closely with cross functional teams to address deviations as well as recommend and implement corrective and preventative actions.
  • Execute major validation projects and ensure adherence to schedule.
  • Communicate validation requirements, timelines, and resource needs to senior management.
  • Work closely with the project team members, including Manufacturing, Engineering, and Quality to incorporate the appropriate elements of quality, equipment, and production into validation strategies.
  • Oversee training and development of staff to ensure compliance with site procedures and regulatory expectations.
  • Develop department goals.
  • Present validation documents and strategies to Senior Management and regulatory agencies when required.
  • Set ambitious and achievable targets to drive for results based on organizational objectives.
  • Build effective cross functional relationships.
  • Interface with peers and colleagues internal and external to identify and implement best practices.
  • Complete/support corrective action plans which address deficient areas identified and ensure adherence to compliance regulations.
  • Organize staff and workload distribution to meet or exceed productivity performance standards.
  • Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting our business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services.  This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Leading People:

  • Leaders motivate, inspire, build, and retain highly effective manufacturing teams while managing for high performance and developing others.
  • They are versatile learners and courageous decision makers.

Leading the Business:

  • Leaders are effective operating in an evolving, complex and dynamic environment, providing clear direction and instruction to direct reports, and continuously looking internally and externally for best practices and areas for improvement.

Delivering to Customers:

  • Leaders understand patient and customer needs and build relationships as required to meet manufacturing goals while continuously improving operations by setting high standards for the team so they may perform to a level of excellence.

Basic Qualifications:

  • Engineering/science bachelor’s degree with a minimum of 10 years Validation/Quality or a master’s degree with a minimum of 8 years of experience in the life sciences regulated industry
  • A minimum of 6 to 8 years of experience in a supervisory or management role.
  • Experience of working in a GMP environment and knowledge of ICH Q8, Q9, Q10 and FDA, ISO and cGMP regulations.
  • Application of risk-based approach to validation (FMEA, PHA, etc.).
  • Knowledge of Validation Lifecycle Approach, such as ASTM E-2500.
  • Experience contributing to regulatory documents development.
  • Excellent technical writing and presentation skills.
  • Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project, and Visio.
  • Experience supporting internal and external audits and oversee closure of all gaps identified during the audits.

Preferred Qualifications:

  • Strong facilitation and team building skills.
  • Energetic in the pursuit of improved processes and ultimately improved performance.
  • Natural leader/influencer, adaptable, flexible as well as a pragmatically minded problem solver.
  • Competent technical knowledge of bio-pharmaceutical plants and manufacturing processes.
  • Innovative and capable of developing alternative solutions to issues at hand.
  • Good communication skills at organization, team, and individual levels.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Have the ability to work weekends when project deliverables/demands require

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now
Validation Supervisor Engineering Cambridge 11/24/2021

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Validation professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Director, Validation at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

Department Description:

The Validation department performs equipment, utility, cleaning, sterilization, software, and process validation activities to ensure compliance with company procedures and industry.  In addition, responsible for equipment ownership and quality assurance review responsibilities associated with site calibration activities.

Position Summary:

Responsible for performing validation in a GMP biotech manufacturing facility.

ESSENTIAL FUNCTIONS

Core Responsibilities:

This position requires both individual responsibilities and supervision of validation engineers, including:

  • Manage validation department personnel including performance evaluation, career development, mentoring and coaching
  • Lead Validation group meetings and collecting and monitoring validation group performance metrics
  • Lead complex validation projects, and the validation aspects of multi-departmental projects
  • Ensure timely execution and closure of scheduled requalifications
  • Ensure timely completion of project activities, including development of system lifecycle documentation, risk assessments, qualifications, and reports.
  • Identify and implement improvements to validation systems
  • Supervise the calibration system and Calibration Coordinator to ensure that scheduled and ad hoc calibrations are performed as required
  • Serve as subject matter expert (SME) for facilities, utilities, and equipment commissioning and qualification (C&Q)
  • Train Validation Engineers on validation concepts and techniques
  • Support investigations into failures of qualified systems, leading as appropriate
  • Develop and revise Validation SOPs to maintain the system in a state of compliance and efficient operation
  • Write, review, and approve validation documentation, including protocols and reports
  • Stay current with industry guidance documents and trends impacting Validation
  • Establish and support a culture of compliance, professionalism, and high performance within the Validation group

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.

Basic Qualifications:

  • Engineering/science bachelor’s degree with a minimum of 4-6 years of validation experience, or master’s degree with a minimum of 2-4 years’ experience.
  • Experience in process, equipment, utility, and/or software validation in a GMP regulated environment.

Preferred Qualifications:

  • Proficient with GE Kaye Validator and/or ValProbe data acquisition systems.
  • Working knowledge of GMPs.
  • Excellent technical writing and verbal communication skills.
  • Basic math and statistical skills.
  • Must be people oriented and a team player.
  • Experience with Microsoft Office including Excel, PowerPoint, Word, Project and Visio.
  • Familiarity with temperature chambers, sterilization, cleaning, software and depyrogenation qualifications.
  • Prior experience with troubleshooting, investigating and effectively documenting deviations and discrepancies on project execution.
  • Experience with writing validation protocols, project plans and final reports and managing validation projects.
  • Ability to read/interpret engineering drawings and design documents.
  • Knowledge of risk management tools and techniques.
  • Prior experience supervising personnel.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • May be required to work in classified and controlled areas such as clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.
  • Able to lift up to 40 lbs.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Apply Now

NASDAQ: VCEL

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