Associate I, Cell Therapy Manufacturing
About The Position
At Vericel Corporation, we are pioneers in 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). Position Summary: The Associate I, Cell Therapy Manufacturing is responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements. Schedule: This role will be required to work on-site Sun-Wed or Wed-Sat.
Requirements
- Bachelor’s degree (Life Sciences or related field) with 0 - 2 years of experience working in a cGMP environment in the biotechnology/pharmaceutical industry or Biotechnology certificate with 1 – 2+ years of experience working in a cGMP environment in the biotechnology/pharmaceutical industry or HS diploma/GED with 4 - 6+ years of cGMP experience.
- Excellent communication skills, written and verbal.
- Experience with Microsoft Office suite.
- Ability to sit for long periods of time while performing cell culture operations.
- Ability to lift, carry, push and pull up to 50 lbs.
- Ability to work 1 weekend day and rotating holiday coverage.
- Ability to gown and gain entry to manufacturing areas.
Nice To Haves
- Experience in small scale tissue culture processing (preferred).
- Experience working within a regulated environment that is frequently audited by internal and external Agencies, such as the FDA and ISO (preferred).
Responsibilities
- Perform manufacturing procedures inside a manufacturing clean room in accordance with established 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 established SOPs.
- Maintain manufacturing-controlled areas in an inspection ready state. Perform clean room equipment sanitization.
- Record equipment and facility metrology data to ensure the equipment operates within specifications. Report out of specification readings to production management.
- Able to work independently upon completion of training. Be receptive to feedback and guidance from manager and other more experienced staff.
- Ability to organize, plan and manage time to effectively complete daily tasks. 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.
- Able to make cell-culture decisions based on cell observations and guidelines in written procedures.
- Assist in reviewing and revising production documents (SOP’s and electronic records).
- Fully trained in at least one unit operation in both product lines.
- Ability to identify and report deviations and contribute to deviation investigations.
- In addition to being fully qualified in MACI or Epicel, cross train and qualify in at least one core competency e.g. 3T3, Media Prep, GP, TrackWise, Veeva.
- Achieve Qualified Trainer status.
- Other duties as assigned.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
