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Account Manager - Midwest Sales-Epicel Chicago, IL - Homebased 06/17/2022

Account Manager - Epicel

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.
  • Ideal Location: Chicago, Detroit, Cleveland

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
Account Manager - West Sales-Epicel West Coast - Homebased 07/26/2022

Account Manager - Epicel

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. 
  • Ideal Location: Southern CA (San Diego, Los Angeles) OR Northern CA (San Francisco, Oakland, San Jose)

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
Associate Director, Payer Contracting Commercial Cambridge 07/25/2022

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 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

Leaderships Qualifications:

Leadership qualifications include, among other requirements:

  • Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics
  • 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.
  • Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

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
Burn Clinical Specialist - Northeast Sales-Epicel Boston North - Homebased 07/28/2022

POSITION SUMMARY

Front line, commercial position responsible for providing support in the procurement of Vericel products and the management of cases from biopsy through surgical procedures and ultimate discharge of burn patients.  Also responsible for providing guidance, support, and input regarding optimal Epicel utilization for care of appropriate burn patients within existing accounts. 

ESSENTIAL FUNCTIONS

Core Responsibilities:

Provide clinical support for patients receiving Vericel products:

  • Full engagement in and intimate knowledge of the care of Vericel burn patients from admission through discharge.
  • Support during various Operating room procedures for each Epicel patient.
  • Awareness of and impact on burn centers’ evolving patient population.
  • Knowledge of various burn product utilization protocols.
  • Train and support all appropriate staff in active accounts and select prospect accounts.
  • Knowledge of all procedures associated with Epicel.
  • Supplies compatible and not compatible with Epicel.
  • Coordinate & lead surgical skills training programs associated with Epicel.
  • Foster development of Key Opinion Leaders (KOLs).
  • Educate key decision makers, including surgeons and support personnel, on Epicel in partnership with BTS team.

Leaderships Qualifications:

  • Leadership qualifications include, among other requirements:

  • Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics
  • 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.
  • Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Basic Qualifications:

  • Bachelor’s or Master’s degree.  
  • 3 to 5+ years of experience with the care of severe burn patients.
  • Experience with hospital operating room environments.
  • 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.
  • Expertise and personality to quickly earn trusted advisor status with key accounts and stakeholders, including top burn experts.
  • Strong clinical and scientific acumen, particularly in burns or wound care, with ability to leverage in training top burn experts and support staff.
  • Ability to thrive in a cross-functional team.
  • Ideal Location: MA, NY, NH 

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 regional travel demands

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
Compliance Specialist, Cell Therapy Manufacturing Manufacturing Cambridge 03/14/2022

POSITION SUMMARY

Department Description:

Manufacturing of cell therapy products.

Position Summary:

The Manufacturing Specialist provides support for projects, manufacturing execution, computer systems (GP, EBR, Preactor), quality systems (deviations, change controls, CAPAs) and implementation of continuous improvement initiatives within the Manufacturing department.
 

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Coordinate and ensure successful completion of manufacturing projects
  • Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
  • Represent Manufacturing on cross-functional teams. Collaborate with other departments including QA, QC, Engineering, Validation, Material Management and Project Management.
  • Assess process manufacturing performance by observation of the floor operations and review of performance data with the objective of implementing process improvement solutions.
  • Lead investigations and provide troubleshooting for deviation reports.
  • Assist in generation of training materials and may assist in providing training on technical aspects of the manufacturing process.
  • Responsible for implementation of corrective actions.
  • Assist with the execution of validation protocols.
  • May participate in regulatory inspections.
  • Participate in tech transfer activities; assess documentation, materials, training, procedures and systems modifications.
  • Own changes or assist manufacturing change owner for changes impacting the process.
  • Lead or participate on the assessment or implementation of special initiatives.
  • May be required to support manufacturing operations during busy times

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leaderships Qualifications:

Leadership qualifications include, among other requirements:

  • Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics
  • 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.
  • Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

  • 2-5 years of experience in a biopharmaceutical manufacturing environment.
  • Familiarity with computer systems such as Preactor, GP, EBR and Trackwise.
  • Must be familiar with biopharmaceutical equipment and systems
  • Experience with cGMP Practices and regulatory requirements.
  • 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:

  • BA/BS in a scientific discipline or equivalent experience preferred.
  • Basic laboratory skills, including working with mammalian cell culture
  • Experience working in an ISO 7 cleanroom environment.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • 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
Customer Care Associate Customer Care Cambridge 07/25/2022

POSITION SUMMARY

Department Description:

Vericel Customer Care Department is responsible for order processing and provides optimum service to both internal and external customers.

Position Summary:

The Customer Care Associate provides daily support for all duties relating to the processing of customer orders via telephone, fax, email, mail orders, price checks, tracking of orders, and confirmation of discounts all within a cGMP environment.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Provide optimal customer service.  All activities are conducted in accordance with company policy, SOPs and HIPAA, FDA, or other internal/external regulatory requirements.
  • Creating electronic and physical patient profiles.
  • Enter critical patient data across multiple systems with a high level of accuracy.
  • Coordinate biopsy collection from facilities via incoming calls from customers.
  • Work closely with customers, team members and sales organization to answer questions, resolve discrepancies in daily operations.
  • Process orders for inventoried items for customers and final product orders with Manufacturing.
  • Coordinate delivery of final product directly with customers.
  • Process product complaints and/or return of goods as applicable.
  • Effectively build working relationships with various internal/external groups such as: Manufacturing, Distribution, Sales, Marketing, Finance, QA, etc.
  • Utilize superior written, verbal and phone skills to handle sensitive information in a timely and organized manner.
  • Contribute to or manage special projects, or perform additional responsibilities as assigned by manager.
  • Be available on-call on a rotating schedule.
  • 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:

  • High School diploma or equivalent and 2+ years of customer service experience.
  • Proficient in Microsoft Office Outlook, Word, and Excel.

Preferred Qualifications:

  • Bachelor’s degree.
  • Experience in ERP systems

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
Engineer II Engineering Cambridge 07/25/2022

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:

  • Lead Engineering specification, estimating, design, procurement, programming, installation management, startup, commissioning, and documentation of new systems and the ongoing support of existing systems.
  • Provide cost estimates for new systems and equipment, and modifications or upgrades to existing systems.
  • Lead design reviews, construction projects and installation support.
  • Perform engineering startup, factory acceptance testing, commissioning, documentation, validation support and operator training.
  • Provide day to day engineering support for process equipment such as Biosafety Cabinets, Freezers, Incubators, Autoclaves, Heat Sealers, etc.
  • Provide day to day engineering support for plant equipment such as RODI Water Systems, Vacuum Pumps, Air Compressors, HEPA Filtration, HVAC, etc.
  • Create and edit SOPs and Quality System Records based on understanding of GMP Facility systems and Engineering Standards.
  • Create engineering Reports and Protocols.
  • Provide support for BMS controls, industrial process instrumentation and PLC control.
  • Develop and maintain corporate engineering specifications, drawings and standards.
  • Other duties as assigned.

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:

  • Bachelor's degree in Mechanical, Chemical or Biomedical Engineering or equivalent engineering field or technical science and 2 or more years of relevant experience.
  • Experience with installing, servicing and maintaining equipment in cleanroom environments.
  • Experience with MS Office: Outlook, Word, Excel, PowerPoint.
  • Experience in writing and editing Technical Reports and Protocols.
  • Experience with Quality Systems.

Preferred Qualifications:

  • Proficient in CAD software, preferably AutoCAD.
  • Exhibits strong communication stills and the ability to work in a cross-functional team environment.
  • The ability to react to changing priorities based on manufacturing or business needs.

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.
  • Required to work with hand tools.
  • Work includes some lifting, up to 50 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
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

Leaderships Qualifications:

Leadership qualifications include, among other requirements:

  • Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics
  • 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.
  • Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

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
IT Compliance Lead Information Technology Cambridge 04/29/2022

POSITION SUMMARY
Accountable for delivering validation knowledge leadership for IT projects by creating computerized systems life cycle documentation, creating and revising IT standard operating procedures and deploying technology solutions to ease the administrative burden in a compliant manner.

ESSENTIAL FUNCTIONS

  • Develop solutions (knowledge base, artifacts, technology) to address IT Quality Compliance needs.
  • Deliver agility to the organization by streamlining IT Change Management and CSV processes.
  • Draft Computer Systems Validation and IT Change Management SOPs to align with GAMP 5 and industry standards.
  • Author, review and update validation documents as necessary for GxP IT implementation projects.
  • Provide Delivery Support to multiple ongoing IT initiatives.
  • Evaluate business requirements and provide solutions based on need.
  • Provide expertise in the areas of IT Quality & Compliance, Computer Systems Validation, Quality assessments, ISO 13485 regulations, 21 CFR Part 11, Annex 11, GxP requirements, Quality System Regulations, CAPA processes, Quality Management Systems design, Supply chain management, process validation and Quality system validation for regulated Life Science environments.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Basic Qualifications:

  • MUST have Pharmaceutical, Bio-Technology, or Life Science industry experience
  • 7+ years of experience in Computer System Validation in a cGMP manufacturing environment.
  • Knowledge of GMPs, GAMP 5, 21 CFR Part 11, Annex 11, MHRA/FDA Data Integrity

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
QC Analyst I Quality Control Cambridge 06/20/2022

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:

Perform routine testing of raw materials, in-process and final products in accordance with SOPs for product release and validation.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Perform microbiological assays for in-process and final product samples.
  • Perform analytical methods for final bulk material/finished goods.
  • Test and disposition of raw materials and perform environmental monitoring.
  • Review of QC data for compliance to procedures and specifications.
  • Calculate and evaluate results.
  • Participate in lab maintenance and administration duties.
  • Initiate lab investigations and deviations.
  • Lab support including but not limited to glass washing, autoclaving, etc.
  • Effectively demonstrate an understanding of CGMPs and how it applies to specific responsibilities.
  • Follow accurate oral and written procedures for testing of in-process and final product samples.
  • Provide input to the technical composition of operating documentation.
  • Work independently under general supervision and direction.
  • Work in compliance with cGMPs.
  • Practice safe work habits and adheres to Vericel’s safety procedures and guidelines.
  • Maintain lab documentation and notebooks, ensuring timely review, reconciliation and filing.
  • Other duties as assigned.

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:

  • Bachelor’s degree or equivalent education and experience.

Preferred Qualifications:

  • 1 year of experience in a CGMP lab environment.
  • Proficient in Outlook, MS Word, Excel and lab based data management systems.
  • Experience with microbiological testing or environmental monitoring.
  • Experience in a biotech, pharmaceutical or other regulated industry.

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
QC Analyst II Quality Control Cambridge 02/08/2022

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 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 current Good Manufacturing Practices (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 microbiological assays for in-process and final product samples.
  • Perform analytical methods for final bulk material/finished goods.
  • Perform maintenance on complex laboratory equipment.
  • Participate in training of less experienced staff.
  • Participate in transfer methods from support groups to the QC laboratory.
  • May perform finished product review and lot release.
  • Coordinate departmental systems (i.e. inventory, documentation, equipment maintenance)
  • Communicate inter-departmentally and with outside contacts to solve technical issues.
  • Exercise sound judgment and decision making when problem solving.
  • Revise standard operating procedures as needed.
  • Perform deviation and lab investigations as needed.
  • Master core responsibilities of a QC Analyst I.
  • Other duties as assigned.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leaderships Qualifications:

Leadership qualifications include, among other requirements:

  • Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics
  • 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.
  • Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

  • Bachelor's degree or equivalent and 3+ years, MS with 0-1+ years of experience in a lab setting.
  • 2+ years of experience in one or more of the following disciplines: microbiology, cell biology and cell culture, flow cytometry and/or molecular biology

Preferred Qualifications:

  • 1+ years of experience in a cGMP lab environment.
  • Proficient in Outlook, MS Word, Excel and lab-based data management systems.
  • Experience with environmental monitoring in a clean room environment.
  • Experience in a biotech, pharmaceutical or other regulated industry.
  • 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.
  • May carry a company issued cell phone for rotating off-shift alarm coverage.
  • 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
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

Leaderships Qualifications:

Leadership qualifications include, among other requirements:

  • Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics
  • 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.
  • Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

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
Senior Manager, Enterprise Information Systems Information Technology Cambridge 04/05/2022

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.

POSITION SUMMARY

  • Lead the design, development, and maintenance of the company’s enterprise systems, including ERP, electronic batch records, scheduling, and other enterprise applications.
  • Hands-on, manager position, leading and mentoring a team of multi-discipline, outsourced IT professionals and developers.
  • Maintain and enhance existing software, and data architecture, warehousing and integration as well as data center hardware.
  • Perform operational as well as strategic leadership to drive the continued evolution of the company's modern architecture.
  • Manage and grow a currently outsourced team, implement new software tools, optimize processes and technology, develop relationships with senior executives, and ensure a high availability all platforms.
  • Support analytics solutions to deliver essential information to satisfy information needs.
  • Proactively plans and executes consistently with a focus on service, operational excellence, critical business functions, evolving internal security and cyber threats.

ESSENTIAL FUNCTIONS

  • Facilitate system lifecycle management including feasibility studies, proof of concepts, pilot projects, and testing while working with stakeholders to define business and systems requirements in a modern data architecture
  • Develop, implement, and maintain all data management policies and procedures, including those for data centers, standards, purchasing, monitoring, and service provision
  • Define the short and long-term strategies for the corporate data and systems management programs to ensure effective delivery of information that meets current and future requirements
  • Provide leadership support to overhaul operations and management where necessary to drive consistent software release management, change management, and project intake and execution processes
  • Collaborate with peers, vendors and other stakeholders
  • Provide leadership support to end-to-end technology roadmap to promote operational and master data excellence
  • Build & cultivate internal and external relationships
  • Oversight and accountability of business plans and budgets while focusing on results and measurements
  • Negotiates vendor arrangements and monitors adherence to agreed-upon service levels.
  • Delivers improvements and changes as necessary to repair recurring issues and to proactively identify and prevent other issues; responsible for multi-year planning of asset upgrades, and replacement, service and maintenance.
  • Establishes the policies, procedures, and practices to operate the company at full capability.
  • Manages outages and events that impact services critical to the business; develops escalation procedures to ensure reliable operations and response to incidents.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Company Technologies:

  • On-prem, SAAS, Hyper-V, SQL, Oracle, SSIS/SSRS, Azure, Dynamics GP ERP, Dynamics 365 CRM, Siemens OpCenter, Microsoft 365, Remote Desktop, Veeam, Zerto

Education: 

  • Bachelor's degree (B.A./B.S.) or equivalent in a directly related discipline.
  • MBA or related Master’s degree preferred.

Experience: 

  • 10+ years related experience, biotechnology and or pharmaceuticals manufacturing required.
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

 

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

Leaderships Qualifications:

Leadership qualifications include, among other requirements:

  • Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics
  • 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.
  • Serving as role models for our fellow employees and business partners 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 Scientist Research and Development Cambridge 05/09/2022

POSITION SUMMARY

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 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.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Demonstrates a comprehensive solid understanding and use of scientific principles and professional practices, to solve a wide range of complex problems in creative and practical ways.
  • Leads cross-functional development teams and provides scientific 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 regards 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.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leaderships Qualifications:

Leadership qualifications include, among other requirements:

  • Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics
  • 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.
  • Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

  • BS and 10+ years of related work experience, or
  • MS and 8+ years of related work experience, or
  • Ph.D. or equivalent in Biology, Biochemistry, Biomedical engineering, Pharmaceutical Sciences or related fields and 6+ years of related work experience.
  • Advanced expertise in mammalian cell culture and related techniques.
  • Familiarity with technical writing and statistical analysis to produce research protocols and reports.

Preferred Qualifications:

  • 6+ years of experience working on development or support of assays and/or manufacturing processes for a biological drug in a GMP facility.
  • 6+ years of experience in isolation and culturing human primary cells.
  • Experience with medium development, cell banking methods and development of cell-based assays.
  • 2+ years of experience in developing autologous cell therapies or tissue engineered products.
  • Extensive hands-on experience in analytical methods for protein, RNA and DNA analysis.
  • Prior experience in cGMP environment and clean room requirements.
  • Prior success with cell-based assay development.
  • Good leadership and people skills, team work 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
Sr. QC Analyst Quality Control Cambridge 06/17/2022

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 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 the company 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 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
Training Lead, Cell Therapy Manufacturing Manufacturing Cambridge 06/24/2022

POSITION SUMMARY

Department Description:

Manufacturing of cell therapy products.

Position Summary:

The Manufacturing Training Lead is responsible for delivering cGMP, technical training. This includes training in the areas of general and advanced knowledge of current regulations, functional job knowledge and skill development, compliance in a cGMP environment. Responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.

ESSENTIAL FUNCTIONS

Core Responsibilities:

Staff Management:

  • Perform manufacturing procedures inside an ISO Class 7 cleanroom in accordance to established SOPs, cGMPs and safety regulations.
  • Perform aseptic manipulations of cell culture processes.
  • Document production operations in corresponding batch records and log sheets according to cGMPs and established SOPs.
  • Input data from production records to existing databases.
  • Develop and maintain a method to ensure that compliance to training is achieved by staff.
  • Deliver and administer On-The-Job (OJT) training across multiple product lines in accordance with safety guidelines, cGMPs and SOPs.
  • Work with the Manufacturing team to evaluate personnel training needs and participate in the development and delivery of training materials.
  • Schedule personnel for the appropriate qualifications such as Gowning, Aseptic Technique, Personnel Qualifications (PQs).
  • Deliver New Hire training and identify needs / solutions for on-going training.
  • Collect and provide data for monthly department training metrics.
  • Participate on training projects with cross functional team members.
  • Plan and drive cross training of the manufacturing groups with measurable time lines.
  • Assist with delivery/training setup for Subject Matter Experts (SMEs) delivering training (WebEx, presentations, etc.).
  • Manage requests and ongoing updates for learning plan requests.
  • Manage course evaluations and other training effectiveness tools (instructor feedback, in class evaluations, exams, etc.).
  • Participate in determining objectives of significant projects or assignments,
  • Able to understand the manufacturing processes in order to assists in reviewing and revising documents.
  • Assists in deviation investigations, CAPAs, risk assessments and change controls.

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.

Basic Qualifications:

  • Bachelor’s degree (Life Sciences or related field) or equivalent with 2+ years of experience in   Manufacturing and/or Quality positions.
  • 2+ years of experience working in cGMP
  • Strong experience with PowerPoint, Word, Excel, and database management and reporting.
  • Ability to work independently under minimal supervision and direction.
  • Ability to take on a leadership role within multiple teams.
  • Strong written and verbal communication skills.

Preferred Qualifications:

  • Previous experience developing and delivering training programs.
  • Ability to assist with cross-functional project work.
  • Organizational and planning skills and the ability to cooperate with others in a team environment will be critical to success.
  • Learning Management System experience.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Flexibility in work schedule.

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 Engineer Engineering Cambridge 08/19/2022

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 standards in support of
Operations and Quality Systems for cell therapies products. The department also functions as the liaison
with the Metrology department and performs all 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:

  • Perform validation activities in the media preparation, cell culture, utilities and QC areas of a cGMP biotech manufacturing facility.
  • Perform hands on execution of Installation, Operational and Performance Qualifications for equipment, facilities, utilities, as well as cleaning, sterilization, and manufacturing processes in accordance with predefined test protocols.
  • Analyze validation results and compile data into reports for initial qualifications and requalifications.
  • Coordinate testing schedule with impacted area managers and quality control based on project needs.
  • Provide input to technical composition of standard operating procedures.
  • Generate custom validation protocols, execute protocols and write final reports.
  • Create department standard operating procedures.
  • Investigate and troubleshoot validation problems.
  • Participate in equipment failure investigations, corrective/preventive actions and equipment release.
  • Play a lead role in the successful completion of project milestones and crucial technical tasks.
  • Provide assistance with Calibration and Metrology liaison responsibilities as department needs require.
  • Routine and effective communication with immediate supervisor and other personnel within the group in addition to outside the department.
  • Review and approve validation documentation.
  • Other duties as assigned.

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:

  • Bachelor's Degree or equivalent work experience and 2+ years validation experience OR Master's Degree and 1+ year validation experience.
  • 1+ years of experience with 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 chamber, 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 and final reports and managing validation projects.
  • Ability to read/interpret engineering drawings and design documents.
  • Knowledge of risk management tools and techniques.


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.
  • May be required to lift, push or pull up to 40 Ibs.

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

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