What are the responsibilities and job description for the Associate II, Cell Therapy Manufacturing position at Vericel Corporation?
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 II, Cell Therapy Manufacturing will be responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.
Schedule: As a company that thrives on teamwork and collaboration, this role will be required to work on-site Sun-Wed or Wed-Sat.
Position Scope:
- 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.
- Perform transactions in ERP system.
- Assist in reviewing and revising production documents (SOP’s and electronic records).
- Ability to identify and report deviations and contribute to deviation investigations.
- Fully trained in at least three unit operations in both product lines.
- In addition to being fully qualified in MACI or Epicel, train and qualify in at least three core competencies, e.g. 3T3, Media Prep, GP, TrackWise, OpCenter APS, Veeva, Qualified Trainer.
- Able to assist in generating an effective production schedule.
- Assists in balancing workload by picking up work from others as necessary.
- Assist Training team in mentoring junior staff. Performs cross training activities.
- Other duties as assigned.
Qualifications:
- Biotechnology certificate with 2 – 4 years of experience working in a cGMP environment in the biotechnology or pharmaceutical industry or GED or equivalent with 6 - 8 years of cGMP experience
- Bachelor’s or higher degree (Life Sciences or related field) or equivalent with 1 – 2 years of experience working in a cGMP environment in the biotechnology or pharmaceutical industry
- Excellent communication skills, written and verbal.
- Experience with Microsoft Office suite.
- 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).
- 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 per week 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 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/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.
