Associate, Cell Therapy Manufacturing

Allogene Therapeutics•Newark, NJ

1d•Onsite

About The Position

Allogene Therapeutics is a clinical-stage biotechnology company developing allogeneic CAR T cell product candidates for cancer and autoimmune disease. The Associate, Cell Therapy Manufacturing will join the Manufacturing team and support tech transfer, operational readiness, and the time-sensitive GMP manufacture and release of cell therapy products. The role is based at the Newark, California location and is onsite five days a week. The associate performs manufacturing and support operations in accordance with SOPs, batch records, cGMP regulations, CFRs, site quality systems, and company policies. The role requires experience in a regulated biotech or pharmaceutical setting and competency in GMP manufacture of cell-based therapies, while promoting quality and compliance. The position may require off-shift work and long hours as needed. Candidates must be authorized to work in the United States. The expected pay range is $43.00–$48.00 per hour; actual compensation depends on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.

Requirements

Bachelor's or associate degree in a relevant science or engineering discipline and 1–3 years of experience in cGMP biologics or cell therapy manufacturing; alternatively, 3+ years 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.
Excellent interpersonal, oral, and written communication skills.
Ability to work off-shift and long hours as required.
Frequent computer monitor, keyboard, and mouse use.
Ability to lift, carry, push, or pull up to 30 pounds; periods of sitting, walking, and standing; and frequent use of personal protective equipment.
Occasional ability to climb stairs or ladders, bend or stoop, crouch or squat, and perform fine finger dexterity tasks including grasping or pinching.
Ability to work with hazardous materials and chemicals, and in cold rooms and freezers.
Color vision and depth perception required for inspection or test-related jobs.
Authorization to work in the United States.

Nice To Haves

Cell culture processing experience handling and propagating human primary cells.
Strong technical writing ability.

Responsibilities

Perform process unit and support operations described in SOPs and batch records, including PBMC, media, and solution preparation; CAR-T cell drug substance preparation; and CAR-T drug product fill operations.
Complete documentation required by protocols, SOPs, and batch records accurately and on time.
Maintain aseptic technique throughout processing, from PBMC thaw through final formulated drug product cryopreservation, to preserve product integrity, viability, and sterility.
Perform work consistently with safety policies, quality systems, and cGMP requirements.
Complete training assignments on time to ensure required technical skills and knowledge are applied compliantly during GMP operations.
Assist in setting up manufacturing areas and equipment, including automated cell processing, cell expansion, and filling equipment.
Update and revise manufacturing operating procedures to ensure technical soundness, effective and efficient operations, and cGMP compliance.
Routinely monitor, clean, prepare, and operate processing and analytical equipment in Grade B/C areas.
Follow facility cleaning and gowning procedures.
Perform accurate calculations of media components, cell concentration, dilution, and viability during production.
Maintain and apply knowledge of donor information, screening and testing, labeling, and product acceptability and release criteria.
Adapt to schedule and procedural changes to support timely preparation of high-quality products.
Maintain current inventory of supplies in designated kitting and staging areas and CAR-T suites.
Perform other duties as assigned.