Vericel® Corporation
Senior Associate, Cell Therapy Manufacturing
Vericel® Corporation, Cambridge, Massachusetts, us, 02140
Senior Associate, Cell Therapy Manufacturing
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Senior Associate, Cell Therapy Manufacturing
role at
Vericel® Corporation
At Vericel Corporation, we pioneer advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting‑edge regenerative medicine. Our commitment to innovation, patient‑centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care).
Schedule:
In‑office Wednesday‑Saturday.
Location:
Split between our new, state‑of‑the‑art facility in Burlington, MA and our current location in Cambridge, MA.
Position Summary The Senior Associate, Cell Therapy Manufacturing will execute process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.
Position Scope
Perform manufacturing procedures inside a clean room in accordance with SOPs, cGMPs, and safety regulations.
Qualified to perform aseptic manipulations of cell culture operations.
Document all operations in Electronic Batch Records and log sheets according to cGMPs and SOPs.
Maintain manufacturing‑controlled areas in an inspection‑ready state and perform clean room equipment sanitization.
Record equipment and facility metrology data to ensure equipment operates within specifications; report out‑of‑spec readings to production management.
Work independently upon completion of training; be receptive to feedback and guidance from manager and more experienced staff.
Organize, plan, and manage time to complete daily tasks; cooperate with others in a team environment.
Practice safe work habits and adhere to Vericel’s safety procedures and guidelines.
Make cell‑culture decisions based on cell observations and guidelines in written procedures.
Assist in reviewing and revising production documents (SOPs and electronic records).
Fully trained in at least one unit operation in both product lines.
Identify and report deviations and contribute to deviation investigations.
Cross‑train and qualify in at least 5 core competencies (e.g., 3T3, Media Prep, GP, TrackWise, Veeva).
Achieve Qualified Trainer status.
Serve as a technical resource for questions and investigate manufacturing issues.
Take on small project work and coordinate with teams to complete the project.
Other duties as assigned.
Qualifications
Bachelor’s or higher degree (Life Sciences or related field) or equivalent with 2–4+ years of experience in a cGMP environment in biotech or pharma.
Biotechnology certificate with 4–6+ years of experience in a cGMP environment or GED or equivalent with 8–10+ years of experience.
Excellent written and verbal communication skills.
Experience with Microsoft Office suite.
Experience in small‑scale tissue culture processing preferred.
Experience working within a regulated environment audited by FDA and ISO preferred.
Ability to sit for long periods while performing physical duties.
Ability to lift, carry, push, and pull up to 50 lbs.
Ability to work one weekend day and rotating holiday coverage.
Ability to gown and gain entry to manufacturing areas.
Why Vericel?
Cutting‑Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
Career Growth: Be a part of a growing organization with opportunities to expand your impact.
Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives.
EEO Statement All applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.
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Senior Associate, Cell Therapy Manufacturing
role at
Vericel® Corporation
At Vericel Corporation, we pioneer advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting‑edge regenerative medicine. Our commitment to innovation, patient‑centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care).
Schedule:
In‑office Wednesday‑Saturday.
Location:
Split between our new, state‑of‑the‑art facility in Burlington, MA and our current location in Cambridge, MA.
Position Summary The Senior Associate, Cell Therapy Manufacturing will execute process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.
Position Scope
Perform manufacturing procedures inside a clean room in accordance with SOPs, cGMPs, and safety regulations.
Qualified to perform aseptic manipulations of cell culture operations.
Document all operations in Electronic Batch Records and log sheets according to cGMPs and SOPs.
Maintain manufacturing‑controlled areas in an inspection‑ready state and perform clean room equipment sanitization.
Record equipment and facility metrology data to ensure equipment operates within specifications; report out‑of‑spec readings to production management.
Work independently upon completion of training; be receptive to feedback and guidance from manager and more experienced staff.
Organize, plan, and manage time to complete daily tasks; cooperate with others in a team environment.
Practice safe work habits and adhere to Vericel’s safety procedures and guidelines.
Make cell‑culture decisions based on cell observations and guidelines in written procedures.
Assist in reviewing and revising production documents (SOPs and electronic records).
Fully trained in at least one unit operation in both product lines.
Identify and report deviations and contribute to deviation investigations.
Cross‑train and qualify in at least 5 core competencies (e.g., 3T3, Media Prep, GP, TrackWise, Veeva).
Achieve Qualified Trainer status.
Serve as a technical resource for questions and investigate manufacturing issues.
Take on small project work and coordinate with teams to complete the project.
Other duties as assigned.
Qualifications
Bachelor’s or higher degree (Life Sciences or related field) or equivalent with 2–4+ years of experience in a cGMP environment in biotech or pharma.
Biotechnology certificate with 4–6+ years of experience in a cGMP environment or GED or equivalent with 8–10+ years of experience.
Excellent written and verbal communication skills.
Experience with Microsoft Office suite.
Experience in small‑scale tissue culture processing preferred.
Experience working within a regulated environment audited by FDA and ISO preferred.
Ability to sit for long periods while performing physical duties.
Ability to lift, carry, push, and pull up to 50 lbs.
Ability to work one weekend day and rotating holiday coverage.
Ability to gown and gain entry to manufacturing areas.
Why Vericel?
Cutting‑Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
Career Growth: Be a part of a growing organization with opportunities to expand your impact.
Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives.
EEO Statement All applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.
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