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Associate Director, Market Access Programs Commercial Cambridge 07/29/2021

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 07/29/2021

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
Buyer/Planner I Material Management Cambridge 07/01/2021

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 Director, 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:

The Materials (Supply Chain) Department and Buyer/Planner I are responsible for ensuring an uninterrupted supply of materials essential for the functioning of assigned product lines and areas.

ESSENTIAL FUNCTIONS

 

  • Review purchase requisitions to ensure that they meet the organization's compliance.
  • Create Purchase Orders; maintain accurate open PO lines to define inbound quantities and due dates from suppliers.
  • Managed returned goods to suppliers.
  • Confirm that modifications and changes to existing orders are properly documented and processed.
  • Track status of back orders and inventory aging report.
  • Partner with internal customers when needed to expedite purchase requisitions or identify solutions for supply chain disruptions which may include the sourcing of alternative providers.
  • Resolve pricing and/or invoicing discrepancies with suppliers.
  • Plans the replenishment of materials to support the production schedule, while controlling inventory turns and materials shortages.
  • Conducts material planning and inventory management for assigned raw materials.
  • Maintains accurate data regarding Bill of Materials associated with all raw materials.
  • Act as liaison with suppliers and Vericel finance during annual standard cost updates.
  • Requests quotes from suppliers, performs new supplier sourcing and evaluation.
  • Adheres to appropriate Standard Operating Procedures for business planning unit to ensure compliance with SOPs, ISO 9000, and cGMP procedures, MRB, Sarbanes-Oxley Controls, and corrective action goals.
  • Other job duties are required.

 

 

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:

  • B.S. degree (or equivalent experience) and 0-2 years of work experience.
  • A.A./A.S and 2+ years of relevant experience.
  • GED, High school diploma or equivalent with and 4+ years of relevant experience.
  • Experience working on cross functional teams.
  • Strong written and verbal communication skills.
  • Proficiency in all Microsoft Office
  • Familiar with Purchasing and Quality Systems.

 

Preferred Qualifications:

  • Experience in Life Sciences.
  • Familiar with cGMP processes.
  • Experience within a regulated environment that is frequently audited by FDA, ISO and other internal and external Agencies.

 

 

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
Buyer/Planner II Material Management 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 Buyer/Planner 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, Supply Chain 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 Materials (Supply Chain) Department and Buyer/Planner II are responsible for ensuring an uninterrupted supply of materials essential for the functioning of assigned product lines and areas.

ESSENTIAL FUNCTION

  • Review purchase requisitions to ensure that they meet the organization's compliance.
  • Create Purchase Orders; maintain accurate open PO lines to define inbound quantities and due dates from suppliers.
  • Managed returned goods to suppliers.
  • Confirm that modifications and changes to existing orders are properly documented and processed.
  • Track status of back orders and inventory aging report.
  • Partner with internal customers when needed to expedite purchase requisitions or identify .solutions for supply chain disruptions which may include the sourcing of alternative providers
  • Resolve pricing and/or invoicing discrepancies with suppliers.
  • Plans the replenishment of materials to support the production schedule, while controlling inventory turns and materials shortages.
  • Conducts material planning and inventory management for assigned raw materials.
  • Maintains accurate data regarding Bill of Materials associated with all raw materials.
  • Act as liaison with suppliers and Vericel finance during annual standard cost updates.
  • Requests quotes from suppliers, performs new supplier sourcing and evaluation.
  • Adheres to appropriate Standard Operating Procedures for business planning unit to ensure compliance with SOPs, ISO 9000, and cGMP procedures, MRB, Sarbanes-Oxley Controls, and corrective action goals.
  • Properly escalate any known supply chain disruptions, order discrepancies or contract matters for internal review and remediation.
  • Create, prepare, and maintain reporting to provide data to monitor trends and allow site business decisions on a timely basis.
  • Other job duties are required.

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:

  • B.S. degree (or equivalent experience) and 2+ years of work experience.
  • A.A./A.S and 4+ years of relevant experience.
  • GED, High school diploma or equivalent with and 6+ years of relevant experience.
  • Experience working on cross functional teams.
  • Strong written and verbal communication skills.
  • Proficiency in all Microsoft Office Applications.
  • Familiar with Purchasing and Quality Systems.

Preferred Qualifications:

  • Experience in Life Sciences.
  • Familiar with cGMP processes.
  • Experience within a regulated environment that is frequently audited by FDA, ISO and other internal and external Agencies.

 

 

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 07/28/2021

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

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 07/19/2021

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.
  • Promote quality customer service standards to ensure high levels are achieved.
  • Resolve complex problems, gather and interpret data.
  • Participate in internal and external audits.
  • Work closely with the sales organization to resolve complex customer issues pertaining to daily operations.
  • 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 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 or equivalent and 2+ years of customer service experience.
  • Proficient in Microsoft Office Outlook, Word, and Excel.

 

Preferred Qualifications:

  • Bachelors degree.
  • Experience in ERP systems.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Able to work a flexible schedule.

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

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

Apply Now
Lead, Manufacturing Manufacturing Cambridge 05/17/2021

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 Lead, 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 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.

Under Manufacturing management guidance, the Manufacturing Team Lead I or II is responsible for oversight of manufacturing activities in the cleanroom for cell therapy products meeting internal and regulatory requirements.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Perform aseptic manufacturing procedures inside an ISO Class 7 cleanroom in accordance to established SOPs, cGMPs, and Safety regulations.
  • Maintain frequent communication with Supervisor to exchange information, recommendations and to review daily cleanroom activities.
  • Under Management guidance, provide consistent, ethical and responsible leadership to manufacturing teams to meet production demands.
  • Provide guidance to staff consistent with cGMP and corporate quality governance.
  • Serve as a liaison between employees and Management.
  • Observe for process consistency within the team and report any observations to Management when problems occur. Receive guidance from Management regarding remediation.
  • Serve as a technical resource for questions and/or investigate manufacturing issues.

Additional Responsibilities:

  • Serve as a Qualified Trainer and assist with staff training.
  • Assist Management with monitoring the staff and workload to meet or exceed productivity performance standards.
  • Recommend ideas for improvement in work practices.
  • Assist technicians with EBR issues and provide technical guidance.
  • May provide input for the development of manufacturing policies (including operational, safety and quality programs).
  • Perform tasks in Manufacturing software systems (e.g., sales order entries, confirming Preactor inventory and setting schedules including changes, GP entry and verification of process work, etc.).
  • May learn the Preactor scheduling system and function as a backup Scheduler.
  • May assist Management with coaching and mentoring of staff in all aspects of their job performance and career development including training, feedback, rewards and disciplinary action.
  • Assist Management by offering feedback for annual performance reviews and provide ongoing input based on established goals.
  • Perform activities within TeamShare (e.g., workflows, periodic reviews, etc.),
  • 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:

  • Biotechnology Certificate with 2+ years of experience (Lead I) or 4+ years of experience (Lead II) working in a cGMP environment in the biotech or pharmaceutical industry.
  • Must possess solid working knowledge of MS Office (Word/Excel/PowerPoint).

Preferred Qualifications:

  • Bachelor’s Degree (Life Sciences or related field) or equivalent
  • Experience within a regulated environment that is frequently audited by FDA, ISO and other internal and external Agencies.
  • Qualified as an On the Job Trainer.
  • Excellent communication skills, written and verbal.

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
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 07/29/2021

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
Principal R&D Associate Research and Development Cambridge 07/09/2021
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 R&D 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.
 
POSITION SUMMARY
Department Description:
 
The Research and Development group within Vericel supports the continuing development, characterization and validation of manufacturing methods, novel assays, new technology and operational improvements. This group manages technology transfers, clinical manufacturing, training, database development, trending analysis and stability. The R&D team plays an important role in commercial manufacturing troubleshooting, root cause investigation, process optimization and product life cycle management.
 
Position Summary:
Responsible for the execution and analysis of experiments and analytical procedures to support the development of robust, cost-effective manufacturing procedures that meet quality, GMP, regulatory and health, safety, and environmental standards. Demonstrate an investigative or technological orientation in designing, executing and interpreting experiments and analytical procedures.
 
ESSENTIAL FUNCTIONS
Core Responsibilities:
  • Works independently to employ in-depth technical knowledge and experience in the development, execution, implementation and troubleshooting of complex experimental procedures and analytical techniques. Approach is reviewed with little to no supervision prior to initiation.
  • Independently defines and implements studies to troubleshoot experimental or analytical procedures.
  • Solutions may involve the formulation and testing of a hypothesis or the development of new techniques and procedures.
  • May lead assay or manufacturing technology transfers between groups/organizations.
  • Designs procedural and experimental approach to meet objectives. Executes experiments and analytical procedures. Interprets results, recommends changes or additional experiments to improve quality, productivity, recovery and efficiency of the manufacturing process or robustness, reliability, ruggedness of analytical procedures.
  • May lead a small project team. Implements project plans and ensures completion within specified timelines. Manages multiple priorities and tasks.
  • Perform culture of human autologous cells, cell based assays, qPCR, and ELISA to support ongoing studies for process development, process improvement, and process validations.
  • Support manufacturing process development by performing analytical testing for the characterization of reference strain banks/cell banks.
  • Develop work plans to ensure the timely completion of several sets of experiments and/or implementation of new manufacturing methods or analytical procedures.
  • Participate in determining objectives of significant projects or assignments and design technical protocol and compile technical reports while maintaining lab notebooks entries to meet objectives.
  • Work is review upon completion for adequacy in meeting desired organizational goals and objectives.
  • Participate in routine lab maintenance activities and media/material ordering.
  • Perform and or oversee internal safety audits of the laboratory/
  • Provide oral presentations on work progress across multi-functional teams.
  • Maintain operational and safe working environment in accordance with BL-2 standards.
  • Represent the organization as a prime contact on contracts or projects.
  • Other duties as assigned.

 

QUALIFICATIONS, EDUCATION AND EXPERIENCE
An ongoing commitment to conducting our business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
Basic Qualifications:
  • Bachelor’s degree or equivalent and 8+ years of relevant work experience.
  • Master’s degree or equivalent and 6+ years of relevant work experience.
  • Experience with cell culture and molecular and cell biology techniques.
  • Experience in analyzing, troubleshooting and interpreting test results, and providing recommendations for method improvement.
  • Effective communication skills both written and oral.
  • Ability to multitask.
Preferred Qualifications:
  • Prior experience in a CGMP and clean room facility requirements.
  • Experience in authoring analytical procedures for execution of testing, cross training, technology transfer and method transfer.
  • Experience/familiarity with cell culture, qPCR, ELISA, cell based assays.
  • Experience with medium development.
  • Experience with cell banking process and development.
  • Experience with cell-based assay development.
  • Self-motivated, organized, familiar with relevant literature, attention to detail.

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 05/07/2021

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 I Quality Control Cambridge 06/03/2021

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:

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

ESSENTIAL FUNCTIONS

Core Responsibilities:

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

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

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

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

Basic Qualifications:

  • Bachelor’s degree or equivalent education and experience.

Preferred Qualifications:

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

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • Ability to lift 40 lbs.
  • Requires working one day per weekend.
  • Rotating holiday coverage.
  • 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
QC Analyst II Quality Control Cambridge 06/03/2021

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 Manager, QC Lot Release 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 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 06/30/2021

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 06/03/2021

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 06/03/2021

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
Receptionist General and Administrative Cambridge 07/22/2021

POSITION SUMMARY

Serve as the first point of contact for all visitors to Vericel. Answer main phone line, direct calls and messages to the appropriate departments and maintain security logs. Provide the highest level of customer service to all employees and outside visitors, vendors, clients as required.

ESSENTIAL FUNCTIONS

  • Answer Vericel’s main phone line and direct callers to appropriate departments.
  • Work with building security to direct visitors to Vericel’s reception area.
  • Greet visitors to the site and prepare visitor passes.
  • Perform support of security monitoring as assigned.
  • Prepare materials for new employees such as Vericel ID badges, building badges, office nameplate, and mailbox.
  • Field emergency calls from within the site.
  • Create, laminate and post various emergency or procedural placards.
  • Deactivate and update employee access badges as needed.
  • Run weekly badging reports.
  • Maintain parking pass validation and EZ Ride logs and run monthly reports.
  • Sort and distribute incoming mail.
  • Manage locker assignments.
  • Assist with office supply orders and distribution.
  • Correspond via email with employees for basic needs.
  • Serve as backup to the Executive Assistant. This may include managing calendars, assisting with Board meetings, travel arrangements and expense reports.
  • Assist with other administrative project as required.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Required Education and Experience:           

  • College degree preferred plus 1+ years of administrative experience OR
  • High school diploma plus 4+ years of administrative experience.
  • Experience with Microsoft Office 365.
  • Excellent customer service and communication skills.
  • Experience in a professional office environment.

Preferred Education and Experience:

  • Experience working with Concur to schedule travel and/or manage expense reports.
  • Experience with coordinating company events/meetings.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • May be required to sit for an extended period of time.
  • May be required to lift up to 25 pounds.

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 06/03/2021

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 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 Manager, Strategic Corporate Finance and FP&A Finance and Accounting Cambridge 05/26/2021

Senior Manager, Strategic Corporate Finance and FP&A

Vericel, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Corporate Finance and FP&A 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.  This highly motivated finance professional will lead financial planning and analysis for our core cell therapy commercial business, our pipeline, and potential business development opportunities.  Reporting directly into the Executive Director of FP&A and Investor Relations at Vericel, this individual will also have an opportunity to support Investor Relations at Vericel, a $2 Billion+ market cap company with a strong institutional shareholder base.  In addition, this finance professional will also have direct exposure to the CFO and CEO of Vericel.

The Senior Manager of Strategic Corporate Finance and FP&A will be responsible for leading corporate and financial planning across Vericel to drive and support the company as it continues to focus on maintaining its high growth profile, across both its current portfolio as well as through potential business development.  In addition, the Senior Manager will support business strategy and decision making, develop robust financial models, and play a key role in supporting the CEO, CFO and Executive Director as well as the Executive Leadership team at Vericel.

In this highly visible role, the Senior Manager will work cross-functionally with leaders across the company to drive both our annual and multi-year corporate planning processes.  Additionally, the Senior Manager will lead key FP&A activities, assist with investor relations and partner with the CEO/CFO and other leaders on strategic projects, including evaluating potential business development and other potential strategic transactions.

Key Responsibilities:

  • Develop, maintain and enhance long term financial model for the company and analyze how investments/changes/strategic scenarios could impact multi-year P&L and value creation
    • Enhance and maintain current year and multi-year corporate model for company
    • Standardize inputs and outputs to ensure model can easily be updated on a regular basis
    • Valuation analysis of existing business and potential strategic transactions using multiple valuation techniques and comparison of company to peers on multiple key metrics
  • Support Business Development & Strategic Transactions
    • Work closely with Executive Director of FP&A and IR as well as CFO and CEO to analyze and provide financial support for potential business development transactions
    • Work closely with Business Development team to develop assumptions and create financial models for potential business development opportunities
    • Create financial analysis for potential business development opportunities including potential pro forma impacts to business
    • Provide financial analysis for other strategic financial and ad/hoc projects
  • Increase decision support across business
    • Ensure we are supporting brands/functions/company to ensure we are optimally investing to achieve highest growth while maintaining strong profitability profile
    • Build out a process for business cases for new areas of investment, capital expenditure requests with a P&L view/mindset and consistent financial metrics
    • Partner with brands/functions - Increase partnership and resources for brand teams to drive ROI/other metrics; provide financial support for marketing plans/resource decisions, ensure plans are supporting assumptions in Budget and Long-Range Plan/multi-year views
  • Improve financial planning, analysis and reporting to keep up with pace of company growth
    • Play lead role in inputs/coordination for Quarterly Forecasts, Annual budgets, LRP inputs/data entry, etc.
    • Maintain key reports/dashboards
    • Prepare key monthly financial reports for ELT and Functions, including analyses of current performance
  • Help to support Investor Relations function and execution
    • Work with Executive Director to be a key contributor to Investor Relations activities
    • Help with preparation of quarterly earnings materials
    • Increase market intelligence and analysis for stock performance, IR reporting and benchmark versus peers

Key Skills Required for Position:

  • Advanced Excel modeling skills
  • Demonstrated ability modeling full financial statements (P&L, Balance Sheet, Cash Flow)
  • Experience with corporate finance, valuation and financial modeling techniques
  • General understanding of capital markets
  • Strategic mindset
  • Willingness to be into the details
  • Strong written (Word & PowerPoint) and verbal communication skills
  • Experience in banking, consulting and/or life sciences preferred
  • Commercial and/or R&D finance life sciences experience preferred but not required
  • MBA preferred

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
Supervisor, Manufacturing Manufacturing Cambridge 07/01/2021

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 Director, 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.

POSITION SUMMARY

Department Description:

Manufacturing of cell therapy products.

Position Summary:

The Supervisor, Manufacturing is responsible for oversight of manufacturing activities for cell therapy products meeting internal and regulatory requirements.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • Master all Team Lead, Manufacturing core responsibilities.
  • Assist in selection, development, and motivation of qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.
  • Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.
  • Coach and mentor staff in all aspect of their job performance and career development including training, feedback, rewards and disciplinary action.
  • Work with team and training leads to develop work plans, assign tasks, and supervise team(s).

Additional Responsibilities:

  • Supervise staff in the Manufacturing environment.
  • Generate the daily manufacturing schedule and master day sheet.
  • Actively perform and oversee daily cell culture activities to assure compliance with all company and regulatory procedures.
  • Conduct annual performance reviews and provide regular feedback based on goals.
  • Organize the staff and workload to meet or exceed productivity performance standards.
  • Complete corrective action plans to address deficient areas identified and to ensure adherence to compliance.
  • Be available on-call.
  • Serve as manufacturing SME for audit activities (internal & external)

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 4+ years of working in GMP environment in the biotech or pharma industry
  • Must possess solid working knowledge of MS Office.
  • Fully trained with manufacturing of one cell therapy product.
  • Schedule for this position is Sunday – Wednesday, 10 hours per day, 1st shift.

Preferred Qualifications:

  • Previous supervisory experience.
  • Experience within a regulated environment that is frequently audited by FDA, ISO and other internal and external Agencies.
  • Excellent communication skills, written and verbal.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • 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
Validation Supervisor Engineering Cambridge 06/03/2021

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 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

$53.57 -0.2 (-0.37%)
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10:25 AM on
July 30, 2021
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