Role Summary
As an entry-level position, this Associate will manufacture HEP & HDF cells under direct supervision from a team leader or supervisor. The Production Associate I will perform all tasks required to produce cells, i.e. spinner preparation, seed, maintain, harvest cells, in a level 10,000 clean room environment in a safe and timely manner. This associate will also assist in the cell banking process when required. The hours for this position are Sunday-Thursday 7:30 am-4:00 pm, some holidays are required.
Responsibilities
- Responsible for manufacturing cells according to established MBR’s and OP’s
- Responsible for adherence to all OP’s, protocols, policies, regulatory requirements, GMP, and safety guidelines
- Responsible for assuring cell culture paperwork is complete and compliant with all protocols
- Responsible for proper operation of all clean room equipment
- Responsible for maintaining all required records & adherence to established guidelines for QC procedures, GMP’s and safety.
- Assist in developing, collecting, trending, and analyzing cell culture technical data
Qualifications
- Required: High school diploma or equivalent. Preferred: Bachelor's degree in Biology or related science. A Certificate or A.S. in Biotechnology with 3-5 years' relevant experience will also be considered.
- Required: Direct experience with cell banking, cell culture, and/or fermentation is highly desired
- Required: Prior experience in general lab techniques including aseptic technique, cGMP and clean room protocols
- Required: Ability to work independently as well as in a team environment
- Required: Aseptic technique, basic lab techniques (pipettes, balances, etc.)
- Required: Remaining in a stationary position, often standing or sitting for prolonged periods
- Required: Communicating with others to exchange information
- Required: Repeating motions that may include the wrists, hands and/or fingers
- Required: Assessing the accuracy, neatness, and thoroughness of the work assigned
Education
- High school diploma or equivalent required. A Bachelor's degree in Biology or related science is strongly preferred. A Certificate or A.S. in Biotechnology with 3-5 years' relevant experience will also be considered.
Additional Requirements
- Medium work that includes moving objects up to 50 lbs.
- Ability to work in a cleanroom environment, for extended periods of time.