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Position Department Location Date
Associate Director, Market Access Programs 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, Market Access Programs will be responsible for leading the partnership with MACI®’s (autologous cultured chondrocytes on porcine membrane) patient service program, MyCartilageCare®. He/she will oversee the operations of the program, liaise with stakeholders, drive strategic growth of MACI via program management, and will be responsible for the overall performance of the program. This role reports to the Market Access Lead at Vericel

ESSENTIAL FUNCTIONS

  • Operational aspects:
    • Execute operational excellence & program oversight including document creation and socialization, performance tracking, vendor training, contract update, vendor performance management
    • Collaborate, manage, influence, and proactively communicate with cross-functional stakeholders and key external partners
    • Review and approve invoices
    • Manage quarterly/annual readout / reporting for programs
    • Proactively identify opportunities / issues leveraging data and business context to enable program improvement
  • Strategic aspects:
    • Derive insights and develop recommendations based on data analytics and tracking to continue optimizing the performance of the program to achieve short-term and long-term goals
    • Assess, manage, and resolve problematic developments and situations
    • Taking a hypothesis and data driven approach, leverage internal and external resources to develop solutions when issues arise
  • Relationship management
    • 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 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:

  • Complying with applicable 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 (Advanced Degree in Healthcare, Healthcare Economics, or Business Administration is preferred)
  • Minimum of 8 years’ experience in reimbursement 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
  • Experience with managing vendor relationships and contracts
  • Disciplined project & program management to deliver and monitor multi-stakeholder plans
  • Strong understanding of medical reimbursement with specialty pharmacies (billing, coding, coverage, and payment) in the healthcare
  • 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, 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 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:

  • Complying with applicable 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
  • 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
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 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 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 - Boston South Sales-MACI Boston South - Homebased 08/11/2021

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 Regional Sales Director 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 of Boston, Cape Cod, Plymouth, Duxbury, New Bedford, Fall River, Brockton, Worcester, Springfield
  • 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 Central Massachusetts 

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 - Buffalo, NY Sales-MACI Buffalo, NY - Homebased 07/28/2021

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 Buffalo, Rochester, Syracuse, Albany
  • 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 Buffalo, Rochester, Syracuse

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
Customer Care Associate Customer Care Cambridge 09/20/2021

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 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:

  • 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
Document Control Specialist, Senior Quality Assurance 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 Document 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 Supervisor, Document Control 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

Work with primary originators of documentation to ensure that documentation is written, edited, reviewed, and approved in compliance with cGMP.

ESSENTIAL FUNCTIONS

  • Initiate QADC SOP improvements and execute document revisions through eWorkflow System.
  • Develop and execute advanced training to QADC and external departments on Document Systems.
  • Work as a team member and lead cross-functional project teams.
  • Identify and facilitate department improvement projects.
  • Ensure GMP documentation is correct, clear, and consistent.
  • Provide advanced guidance to employees as needed.
  • Participate in internal audits to ensure compliance to cGMPs.
  • Support remediation efforts that are applicable to documentation.
  • Facilitate the Document Periodic Review Program.
  • Prepare and manage data to be archived to off-site storage facility.
  • Perform data entry for tracking documents and departmental metrics.
  • Maintain controlled documents in strict compliance to corporate policies and regulations.
  • Facilitate the effective processing of Quality System documents to ensure they are maintained and archived in an organized and retrievable state for accountability and access for any regulatory body.
  • Conduct investigations and change controls as applicable.
  • 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:

  • High School degree or equivalent and 7+ years of related experience, or
  • Associates degree or equivalent and 5+ years of related experience
  • 2-4 years of MS Office Suite experience; MS Word - ability to create / modify templates, knowledgeable with styles formatting, hyperlinking and track changes functionality;
    MS Excel - ability to generate spreadsheets with applied knowledge of formula creation and maintenance, charting and formatting
  • Strong written and oral communication skills
  • Time management skills
  • Strong attention to detail

Preferred Qualifications:

  • College degree or equivalent in related field
  • Extensive experience with working in a Document Management System (i.e. Livelink, Documentum, etc.)
  • Quality Management System (Deviations, CCRs, etc.) experience
  • Technical writing experience

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Ability to lift and carry up to 40 lbs
  • May require 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
Engineer I Engineering Cambridge 08/10/2021

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 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 Associate Director, Engineering & Facilities 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:

  • Assist in providing engineering support for new and existing process and utility system installations.
  • Assists with the specification, estimating, design, procurement, programming installation management, startup, commissioning and documentation of new systems and the ongoing support of existing systems under close supervision.
  • Support Validation department by assisting in execution and completion of design reviews, construction and installation support.
  • Assist in the preparation of engineering turnover packages.
  • Supports system progress and as-built walk downs during construction and installation.
  • Participate in ongoing support of manufacturing equipment, facilities, and utility systems.
  • Participate in closure of deviations, CAPA’s and change controls for manufacturing equipment.
  • 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 Biomedical, Chemical, or Mechanical Engineering or a related engineering field.
  • 0-2 years of relevant experience.
  • Experience with MS Office: Outlook, Word, Excel, PowerPoint.

Preferred Qualifications:

  • Exhibits strong communication stills and the ability to work in a team environment.
  • The ability to react to changing priorities based on manufacturing or business needs.
  • Experience in technical writing.

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
LMS Supervisor Quality Assurance Cambridge 08/05/2021

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 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

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
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 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:

  • 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, Regulatory Affairs Regulatory Cambridge 08/17/2021

POSITION SUMMARY

The 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 INDs, BLAs, MAAs and other dossiers as required for investigation and registration of medical products in the US and abroad.
  • 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.
  • Assist in SOP generation and contribute to improvements in department best practices.
  • 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 in Regulatory Affairs (preferred)

Basic Qualifications

  • 3-5 years Regulatory Affairs experience for pharmaceutical, biotech, or medical device products in the US market (or equivalent).
  • Combination product experience a plus.
  • Experience and knowledge in preparation of INDs, BLAs, and supportive amendments and supplements.
  • Working knowledge of FDA and ICH regulatory guidance and regulations. 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
Manufacturing Technician Manufacturing Cambridge 06/01/2021

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 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:

  • 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
Market Access and Pricing Analytics Manager 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 Market Access and Pricing (MAP) Analytics Manager will be responsible for all MAP-related data analytics to support the MAP function at Vericel. He/she will provide tracking and monitoring, identify trends and valuable information for MAP operations (including patient services analytics), and establish and maintain price and contract management capabilities. This role reports to the Market Access Lead at Vericel

ESSENTIAL FUNCTIONS

  • MAP analytics:
    • Establish and maintain a database for price management (list and net) and work with internal cross-functional teams and external partners in customer-level price execution
    • Conduct analyses to guide pricing decisions
    • Collaborate with relevant partners to conduct payer analyses to support payer engagement strategy
    • Support pricing and market access projects, including studies for in-market products (MACI®, Epicel®), pre-launch product(s), and MAP opportunity assessment for business development
  • Patient Service Program analytics:
    • Build out data model and analytical capabilities for program monitoring
    • Track, report, and analyze trends and performance to address business needs
    • Utilize KPIs and other performance diagnostics to provide weekly / monthly / quarterly updates
    • Collaborate with internal teams, alliance partners, and vendors to coordinate cross-functional analyses

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting 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:

  • Complying with applicable 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 (Advanced Degree in quantitative field is preferred)
  • Minimum of 5 years’ experience in pharmaceutical / biotech products analytics in a commercial setting
  • A strong sense of responsibility and accountability
  • Experience with longitudinal patient, specialty pharmacy, and hub data preferred
  • Familiarity with commercial business intelligence tools for report creation
  • Prior exposure to managed care data sources and claims data
  • Strong presentation & 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
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 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 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
QC Analyst II Quality Control Cambridge 09/14/2021

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 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 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 an Analyst I.
  • 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 and 2+ years of experience in a lab setting.

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, biological assays, or environmental monitoring.
  • Experience in a biotech, pharmaceutical or other regulated industry.
  • Excellent communication skills, verbal and non-verbal desired.
  • Excellent technical writing and investigational skills.
  • Experience with PCR based methodology or cell culture methods.
  • 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.
  • Rotating off-shift alarm coverage. Must carry a company issued cell phone.
  • 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 Assurance Specialist I Quality Assurance Cambridge 08/03/2021

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 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:

  • High School Diploma plus 1 year of GMP experience

Preferred Qualifications:

  • 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 40 lbs.
  • Must work 1 weekend day.
  • Rotating holiday coverage.
  • Schedule: Tuesday-Saturday, 8:00am-4:30pm

 

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 08/03/2021

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 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:

  • High School Diploma 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

  • Able to lift and transport up to 40 lbs
  • Must work 1 weekend day (Schedule: Tuesday-Saturday)
  • 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 08/03/2021

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 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
Scientist II Research and Development 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 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 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:

  • 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 Medical Director, Burn Care Franchise Medical/Clinical Pharma Cambridge 06/09/2021

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 Medical 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.

POSITION SUMMARY

The Senior Medical Director, Burn Care Franchise, will be responsible for providing medical expertise regarding all aspects of burn care at Vericel.  She/he will report to the Chief Medical Officer and be the primary medical interface between the Company and burn surgeons, nurses and other healthcare professionals, and will support educational activities, scientific/clinical development and the Company’s field-based Burn Care Medical Affairs and Commercial teams.

ESSENTIAL FUNCTIONS

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Operational

  • Support the Chief Medical Officer, providing medical expertise regarding all aspects of burn care at Vericel.
  • Serve as the primary medical interface between the Vericel Clinical team and practicing burn surgeons, nurses and other healthcare professionals.
  • Develop and execute the Clinical and Medical Affairs strategy for the Burn Care Franchise.
  • Work collaboratively with and support the field-based Medical Science Liaisons on the Burn Care team.
  • Provide strategic support and direction to the Epicel and NexoBrid Brand teams and day-to-day support to the Burn Care Specialists on the Commercial team.
  • Provide education on the management of patients with burn injuries to internal Vericel teams and external audiences.
  • Attend appropriate conferences and monitor the scientific literature for changes in clinical practice and scientific advances that may influence future activities and strategic direction of the Burn Care Franchise.  .
  • Provide strategic and executional support to the Clinical Operations and Medical Affairs teams during the planning and execution of pre- and post-market clinical trials and evidence development activities.
  • Present brand related outcomes data and updates at professional conferences as appropriate.
  • Serve as an interface between Vericel and relevant professional organizations such as the American Burn Association, North American Burn Society, the U.S. Food & Drug Administration and other regulatory authorities as required.
  • Provide input as required to Business Development team for the burn care franchise with respect to strategic direction as well as in-depth assessments of additions to product portfolio including line extensions.
  • Work in close collaboration with Commercial Team including Marketing, Advocacy Development and Sales Training in the development and communication of educational content to both internal and external stakeholders.

Financial

  • Assist in forecasting, planning and execution of departmental budget and ensure that monthly expenses are in line with the budget.

Leadership Qualifications

Vericel is committed 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 locations where we conduct business, as well as our Vericel’s internal 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.
  • Serving as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Qualifications:

  • MD with 10 years clinical experience as Board Certified burn surgeon.
  • Demonstrated expertise in clinical research, project development and execution and ICH Good Clinical Practice requirements.
  • Excellent verbal, presentation, and written communication skills.
  • A track record of clinical and scientific publications.
  • Experienced leader with collaborative management style, motivational and fair with skills in diplomacy, consensus building, negotiation, problem solving and the ability to gain confidence and trust of others.
  • History of successful industry experience.

WORKING CONDITIONS AND PHYSICAL DEMANDS

Expected to travel up to 70% and live within 30 miles of major airport hub

 

 

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
Talent Acquisition Partner Human Resources 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 Talent Acquisition 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 Talent Acquisition Lead 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 Talent Acquisition Partner will support and execute talent acquisition and HR functions for the corporation in partnership with the Talent Acquisition Lead and the Human Resources team. The Talent Acquisition Partner will be responsible for sourcing, screening, interviewing, hiring and onboarding candidates for assigned positions, and will provide ad hoc HR support to site management and personnel. .

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Manage the hiring lifecycle for specific positions: post jobs, screen candidates, arrange interviews, collect feedback, negotiate offers, conduct reference and background checks, and coordinate onboarding.
  • Plan recruiting strategy with hiring managers.
  • Successfully and professionally represent the Company as the candidates’ first point of contact.
  • Track candidate lifecycle through applicant tracking system.
  • Document candidate evaluation and interview process
  • Manage relationships with recruiting agencies.
  • Provide regular updates to hiring teams and candidates throughout process.
  • Follow established hiring, onboarding and offboarding processes and coordinate details for all new hires and exiting workers, ensuring proper handling of assets and systems and facility access.
  • Ensure compliance with Vericel’s Affirmative Action Program.
  • Support diversity and inclusion corporate initiatives
  • Maintain current knowledge and ensure compliance with federal, state and local HR laws.
  • Assist in the development and execution of HR training programs.
  • Under the guidance of HR leadership, coordinate event planning and catering for HR-sponsored company events.
  • Oversee internal job applications and manage communication between management and internal applicants.
  • Contribute to development of SOP’s, process improvements and implementation of new technologies.
  • Assist with ad hoc HR projects and priorities in support of changing business needs.
  • Assist employees with HR or employee relations questions and concerns.
  • Other duties as required.

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.
  • Being responsible, fair and honest in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

  • Bachelor’s degree in Human Resources or related field.
  • Previous recruiting or talent acquisition experience
  • Ability to work with discretion to ensure confidentiality as appropriate
  • Excellent MS Office skills: Outlook, Word, Excel, PowerPoint.
  • Strong written and verbal communication skills.
  • Excellent attention to detail, organization, and teamwork.
  • Sense of urgency to move the recruitment process forward, with a tactful and professional drive for results.
  • Ability to build lasting professional relationships with internal customers, recruiting agencies and candidate pool.

Preferred Qualifications:

  • Previous experience working in Human Resources
  • Previous experience scheduling meetings in a high-volume environment
  • Experience working with an electronic Applicant Tracking System
  • Previous experience hiring for biotech, pharmaceutical and medical device companies

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 08/04/2021

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 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:

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 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 and 6+ years of validation experience, or
  • Master’s Degree or equivalent and 4+ years of validation experience.
  • 3-4 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, 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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September 22, 2021
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