Cell Therapy Manufacturing Associate WaveCrest Staffing Group - 3.4 Newark, CA Job Details Contract $40 - $44 an hour 21 hours ago Benefits Health insurance Dental insurance 401(k) Paid time off Qualifications Biological safety protocols Pharmaceutical regulatory compliance Safety regulations Hazardous materials handling safety protocols Cleanroom protocols Personal protective equipment (PPE) adherence Manufacturing facility experience Sterile field contamination management Cleanroom experience Safety equipment Quality systems Sterile medication handling Associate's degree FDA regulations Pharmaceutical manufacturing facility experience Full Job Description About the

Role:

We are seeking a highly motivated Associate to join a Manufacturing team supporting cell-based cancer immunotherapy production. This role supports tech transfer and operational readiness, applying cGMP knowledge to ensure manufacturing readiness. Core responsibilities include ensuring the successful, time-sensitive GMP manufacture and release of cell therapy products, following all cGMP/CFR/site quality system requirements, and promoting a culture of quality and compliance.

Responsibilities:

Perform process unit and support operations per SOPs and batch records, including PBMC/media/solution preparation, cell drug substance preparation, and drug product fill operations Complete required documentation accurately and on time per protocols, SOPs, and batch records Maintain aseptic technique throughout processing to preserve product integrity, viability, and sterility from cell thaw through final formulated drug product cryopreservation Perform tasks consistent with safety policies, quality systems, and cGMP requirements Complete training assignments on time to maintain compliant technical skills and knowledge Assist in setting up manufacturing areas and equipment, including automated cell processing, expansion, and filling equipment Update and revise manufacturing operating procedures for technical soundness, efficiency, and cGMP compliance Monitor, clean, prepare, and operate processing and analytical equipment in Grade B/C areas

Requirements:

Bachelor's or Associate's degree in a relevant science or engineering discipline 0-2 years of experience in cGMP biologics or cell therapy manufacturing Aseptic processing experience in Grade A biosafety cabinets and Grade B clean rooms Cell culture processing experience with human primary cells strongly preferred Familiarity with universal precautions for handling human-derived materials in BSL-2 containment Knowledge of cGMP regulations and FDA guidance for biologics and/or cell therapy Strong technical writing ability strongly preferred Excellent interpersonal, oral, and written communication skills Ability to work off-shift and long hours as required Physical requirements: frequent lifting/carrying/pushing/pulling up to 30 lbs, frequent sitting/walking/standing, frequent PPE use, occasional climbing/bending/stooping/crouching, occasional fine finger dexterity, occasional use of hazardous materials/chemicals, occasional work in cold rooms/freezers, color/vision/depth perception required Must be authorized to work in the U.S.

Pay:

$40.00 - $44.00 per hour Expected hours: 40.0 per week

Benefits:

401(k) Dental insurance Health insurance Paid time off

Work Location:

In person