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Associate I, Cell Therapy Manufacturing
2 months ago
Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing manufacturing professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to Manufacturing Management at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.
POSITION SUMMARY
Responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.
Essential Functions:
- Master core responsibilities of a Manufacturing Tech, Senior.
- Effectively report deviations and contribute to deviation investigations in TrackWise.
- Able to train in the role of an On the Job Trainer and become a Qualified Trainer.
- Able to make cell-culture decisions based on cell observations and guidelines in written procedures.
- Perform transactions in ERP system.
- 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, OpCenter APS, Veeva, QT.
- Other duties as assigned.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
- Bachelor’s or higher degree (Life Sciences or related field) or equivalent with 0 - 2+ years of experience working in a cGMP environment in the biotechnology or pharmaceutical industry
- Biotechnology certificate with 1 – 2+ years of experience working in a cGMP environment in the biotechnology or pharmaceutical industry or GED or equivalent with 4 - 6+ years of cGMP experience.
- Excellent communication skills, written and verbal.
- Experience with Microsoft Office suite.
Preferred Qualifications:
- Experience in small scale tissue culture processing.
- Experience working within a regulated environment that is frequently audited by internal and external Agencies, such as the FDA and ISO
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 per week.
- Rotating holiday coverage.
- Ability to gown and gain entry to manufacturing areas.
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.
