Manufacturing Associate - Biologics
Edison-New Brunswick Metro Area, NJ
- 4-year degree, B.S. in Biology, Biochemical, Chemical, or Biomedical Engineering or related discipline with 1-3 years of relevant experience in a clinical laboratory or blood/cell culture processing environment.
Ability to work in an aseptic environment requiring successful completion of qualification program.
- Manufacture clinical grade cellular therapeutic products to supply the Clinical Program:
o Execute/Implement batch records in ISO 7 & 8 clean room environments.
o Observe, practice, and promote all aspects of the GMP & GDP requirements.
o Complete and maintain aseptic processing and sterile gowning qualifications.
o Communicate with Quality Control to ensure proper handoff of process samples.
Maintain laboratory and equipment for cleanliness and compliance.
o Complete room activity, maintenance, cleaning, and equipment usage logs.
o Run daily calibration checks on equipment where appropriate, and escalate deviations.
o Perform daily, weekly, and extended cleaning of laboratory areas and equipment.
o Ensure sufficient laboratory supplies for daily laboratory operations.
Assists with development of Standard Operating Procedures (SOPs) and/or production batch records associated with new processes that are transferred from Development into Manufacturing Operations
Interact with Supply Chain, Facilities, and Development as needed to ensure smooth operation, and escalate any issues involving safety or product quality up the appropriate channels.
Collaborate with members of internal teams to drive process improvements and assist with implementation of changes by utilizing quality systems.