Associate Cell Therapy Manufacturing

ACL Digital; Newark (CA); On-site; USD 55,000 - 75,000; Full time

Job summary

ACL Digital is seeking an Associate Cell Therapy Manufacturing professional in Newark, CA to perform CAR-T manufacturing operations in a cGMP setting. The role involves preparing PBMCs, media, and drug substance, with emphasis on aseptic technique and accurate documentation.

Ideal candidates have a 0–2 year background in cGMP biologics or cell therapy, strong writing skills, and the ability to work off-shift as needed. Training and safety compliance are integral to the role.

Qualifications

• Bachelor's or Associate's degree in science or engineering with exposure to cell therapy/manufacturing.
• Experience with cGMP biologics or cell therapy manufacturing preferred.
• Aseptic processing in Grade A/B environments and handling human-derived materials.
• Strong written and verbal communication; ability to work in a team.

Responsibilities

• Perform process unit and support operations per SOPs and batch records for CAR-T manufacturing.
• Prepare PBMC, media, solutions; and CAR-T drug substance and product fill operations.
• Document accurately and timely per protocols and batch records.
• Maintain aseptic technique to ensure sterility and viability of products.
• Complete training and stay aligned with GMP requirements and safety policies.
• Assist in setting up manufacturing areas and complex automated equipment.
• Monitor and operate equipment in Grade B/C areas; follow gowning procedures.
• Compute media components, cell concentrations, viability, and dilutions.
• Maintain donor information and release criteria; adapt to schedule changes.
• Keep inventory of supplies in kitting and CAR-T suites; perform other duties.

Skills

cGMP biologics

Cell therapy manufacturing

Aseptic processing

Documentation

Interpersonal communication

Education

Bachelor's or Associate's in relevant science or engineering

Job description

Job 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

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

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

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 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.

Education:

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