Associate, Cell Therapy Manufacturing

About the role:

We are seeking a highly motivated Associate, Cell Therapy Manufacturing to join our Manufacturing team. This is a 6+ month contract role that could be extended before a decision on the full-time role is made. This role will work within the Manufacturing team in supporting our efforts in an exciting new area of cancer immunotherapy. This position is based out of Newark, CA.

The position will support the successful tech transfer and operational readiness process, using knowledge of cGMP regulations to ensure manufacturing readiness. Responsibilities of primary importance are: to ensure the successful, time-sensitive GMP manufacture and release of cell therapy products; to follow all processes and procedures related to operations in full compliance with cGMP, CFRs, site quality systems and company policies; and to promote a culture of quality and compliance.

The successful candidate will have experience in a regulated biotech or pharmaceutical setting and will have proven competency and expertise in the GMP manufacture of cell-based therapies.

Responsibilities include, but are not limited to:

• Perform process unit and support operations described in standard operating procedures (SOPs) and batch records including: PBMC, media and solution preparation; CAR-T cell drug substance preparation; and CAR-T drug product fill operations
• Accurate and timely completion of documentation required by protocols, SOPs, and batch records
• Maintain aseptic technique during processing of products to ensure the integrity, viability and sterility of cell therapy products from PBMC thaw to final formulated drug product cryopreservation
• Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements
• Timely completion of training assignments to ensure the necessary technical skills and knowledge are applied compliantly during GMP operations
• Assist in setting up manufacturing areas and equipment, including complex automated cell processing, cell expansion and filling equipment
• Update and revise manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
• Routinely monitor, clean, prepare and operate processing and analytical equipment in Grade B/C areas
• Follow all cleaning and gowning procedures for the facility
• Perform error free calculations of media component and cell concentration, dilution, viability during production
• Must maintain and apply knowledge regarding donor information, screening and testing, labeling and product acceptability and release criteria
• Be flexible and adaptable to schedule and procedural changes to ensure timely preparation of products with highest quality
• Maintain current inventory of supplies kept in specified kitting and staging areas and CAR-T suites
• Other duties as assigned

• Position Requirements & Experience:

  • Bachelors or Associates in relevant science or engineering discipline with 0-2 years of experience in cGMP biologics or cell therapy manufacturing
  • Aseptic processing in Grade A biosafety cabinets and Grade B clean rooms
  • Cell culture processing experience in handling and propagation of human primary cells is strongly preferred
  • Universal precautions for handling human derived materials in BSL-2 containment areas
  • Knowledge of cGMP regulations and FDA guidance applicable to biologics and/or cell therapy
  • Excellent interpersonal, oral and written communication skills
  • Strong technical writing ability is strongly preferred
  • Ability to work off-shift and long hours as required
  • Frequent use of a computer monitor, keyboard and mouse required
  • Frequent lifting, carrying, pushing or pulling up to 30 pounds required
  • Frequent periods of sitting, walking, and standing required
  • Frequent use of personal protective equipment required
  • Occasional climbing stairs or ladders, bending or stooping, crouching or squatting required
  • Occasional fine finger dexterity/ including grasping or pinching required
  • Occasional use of hazardous materials and chemicals required
  • Occasional work in cold rooms and freezers required
  • Color, vision, and depth perception required for inspection or test related jobs.
  • Candidates must be authorized to work in the U.S.
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
  • Ability to work independently and as part of a team.
  • Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
  • Candidates must be authorized to work in the U.S.

• Bachelors or Associates in relevant science or engineering discipline with 0-2 years of experience in cGMP biologics or cell therapy manufacturing