Cell Therapy GMP Manufacturing Associate

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

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.