Manufacturing Associate

ACL Digital; Newark (CA); On-site; USD 70,000 - 95,000; Full time

Job summary

ACL Digital is seeking an Associate for Cell Therapy Manufacturing in Newark, CA. The role involves performing cell processing operations per SOPs, preparing CAR-T products, and handling PBMC workflows in a GMP environment.

The candidate will maintain aseptic technique, complete batch records, and participate in equipment setup and SOP updates to ensure compliant and efficient operations in Grade A/B areas. Training and safety compliance are essential parts of the role.

Qualifications

• Bachelor's or Associates in relevant science or engineering with 0–2 years in cGMP biologics or cell therapy.
• Aseptic processing in Grade A/B clean rooms with proper PPE.
• Experience with cell culture handling of human primary cells preferred.
• Knowledge of cGMP and FDA guidance for biologics/cell therapy.

Responsibilities

• Perform process unit and support operations per SOPs and batch records (PBMC, media, solutions; CAR-T substance preparation; cell product filling).
• Accurate and timely completion of documentation required by protocols, SOPs, and batch records.
• Maintain aseptic technique to ensure integrity, viability, and sterility from PBMC thaw to final cryopreservation.
• Follow safety, quality systems, and cGMP requirements; complete training assignments in GMP operations.
• Assist in setting up manufacturing areas and equipment, including automated cell processing and filling equipment.
• Update manufacturing SOPs to improve efficiency and maintain cGMP compliance.
• Routinely monitor, clean, and operate processing and analytical equipment in Grade B/C areas.
• Follow all cleaning and gowning procedures for the facility.

Skills

Aseptic processing

Cell culture handling

cGMP knowledge

BSL-2 containment

Documentation accuracy

Education

Bachelor's degree in science or engineering

Associates degree acceptable

Job description

Title: Associate, Cell Therapy Manufacturing

Location: Newark, CA 94560

Duration: 12 months

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

Skills:

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