Manufacturing Associate

WaveCrest Staffing Group; Newark (CA); On-site; USD 52,000 - 61,000; Full time

Job summary

WaveCrest Staffing Group seeks an Associate, Cell Therapy Manufacturing in Newark, CA to support a new cancer immunotherapy program. The role involves tech transfer, quality documentation, and maintaining cGMP readiness for CAR-T processes.

The position requires 0–2 years in cGMP biologics or cell therapy manufacturing, aseptic processing experience, and a strong commitment to safety and quality in a GMP setting. First shift, 1 year contract with potential extension.

Qualifications

• 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.
• Experience with aseptic processing in Grade A biosafety cabinets and Grade B clean rooms.
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and/or cell therapy.

Responsibilities

• Perform process unit and support operations described in SOPs and batch records, including CAR-T related steps.
• Accurately complete documentation required by protocols, SOPs, and batch records.
• Maintain aseptic technique to ensure sterility of cell therapy products.
• Operate and monitor processing equipment following safety policies and cGMP requirements.
• Set up manufacturing areas and equipment, including automated cell processing and filling.
• Update manufacturing operating procedures to ensure compliance and efficiency.

Skills

cGMP

Aseptic processing

Cell therapy

Documentation

Safety compliance

Education

Bachelor's or Associate's degree in science/engineering

Job description

Our client is a major biotechnology therapeutics manufacturer and is seeking a highly motivated Associate, Cell Therapy Manufacturing to join our Manufacturing team. This role will support our efforts in an exciting new area of cancer immunotherapy. The position will support the successful tech transfer and operational readiness process, using knowledge of cGMP regulations to ensure manufacturing readiness.

Located in Newark, CA

1 year contract w/extension

Pay: $38-44/hour

1st shift

Key Responsibilities

• 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
• Accurately and timely complete 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.
• Complete training assignments in a timely manner 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, and viability during production.

Qualifications & Experience

• Bachelor's or Associate's degree in a relevant science or engineering discipline with 0–2 years of experience in cGMP biologics or cell therapy manufacturing.
• Experience with 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.
• Experience with 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.

**This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!**