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Role Summary
Entry-level Production Associate I responsible for manufacturing HEP and HDF cells under direct supervision in a level 10,000 clean room. The role involves spinner preparation, seeding, maintaining, and harvesting cells, and may assist with the cell banking process.
Responsibilities
- Manufacture cells according to established MBRs and OPs.
- Adhere to all OPs, protocols, policies, regulatory requirements, GMP, and safety guidelines.
- Ensure cell culture paperwork is complete and compliant with all protocols.
- Operate clean room equipment properly.
- Maintain all required records and adhere to established guidelines for QC procedures, GMP, and safety.
- Assist in developing, collecting, trending, and analyzing cell culture technical data.
Qualifications
- High school diploma or equivalent required. A Bachelor's degree in Biology or a related science discipline is strongly preferred. A Certificate or AS in Biotechnology with 3-5 years' relevant experience will also be considered.
- Direct experience with cell banking, cell culture, and/or fermentation is highly desired.
- Prior experience in general lab techniques including aseptic technique, cGMP and clean room protocols is desired.
- Ability to work independently as well as in a team environment.
- Aseptic technique and basic lab techniques (pipettes, balances, etc.).
- Remaining in a stationary position, often standing or sitting for prolonged periods.
- Communicating with others to exchange information.
- Repeating motions that may include the wrists, hands and/or fingers.
- Assessing the accuracy, neatness, and thoroughness of the work assigned.
Additional Requirements
- Physical Requirements: Medium work that includes moving objects up to 50 lbs.
- Environmental conditions: Ability to work in a cleanroom environment for extended periods of time.