Cell and Gene Therapy Specialist I

Genentech•Los Angeles, CA

2d•Onsite

About The Position

The Cell and Gene Therapy Specialist I is part of the Genentech San Diego internal manufacturing team, supporting the pre-clinical and clinical production of cell therapies. This role involves supporting process tech transfers, routine GMP production activities, and technology improvements to ensure the successful delivery of released product for Genentech San Diego’s clinical trials. The work is performed in a GMP manufacturing facility, requiring standing or sitting in a cleanroom environment, walking around the facility, and adhering to strict gowning requirements and protective clothing protocols.

Requirements

Bachelor’s degree in biology, Chemistry, or Engineering preferred OR 2+ years of related GMP experience (an equivalent combination of education and experience may be considered)
Experience in the biotechnology industry in a GMP environment is preferred.
Prior experience with cell or gene therapy manufacturing is a plus
Demonstrated aseptic techniques
Able to lift 40 pounds and stand for hours at a time.
Flexible to work off-shift hours, weekends, and some holiday work
Excellent proficiency in Microsoft Word, Excel, and PowerPoint.
Self-motivation and a positive attitude, with a willingness to take on temporary responsibilities outside the initial job description.
Ability to adapt to a fast-paced, constantly evolving environment while thinking creatively and proposing innovative solutions.
Ability to follow verbal and written instructions accurately, ensuring effective communication and task execution.
Strong problem-solving skills to address challenges and develop practical solutions.
Ability to collaborate effectively as a team player to contribute to collective goals and maintain a supportive work environment.

Nice To Haves

Prior experience with cell or gene therapy manufacturing

Responsibilities

Performing critical GMP aseptic operations in Grade A and Grade B production environments by following batch records, SOPs, policies, and work instructions to ensure safety and compliance.
Assisting in all areas of cell therapy operations, including stocking, tracking inventory, material movement, maintaining metrics, filling log sheets, and supporting special projects as needed.
Supporting startup activities for a new cGMP facility by collaborating with Process Development, MSAT, Facilities, and Quality departments.
Escalating processing and equipment issues when necessary, participating in deviation writing, root cause investigations, and implementing CAPAs when required.
Collaborating with Supply Chain, Process Development, Facilities, and Quality teams to execute GMP operations while prioritizing a right-the-first-time philosophy and fostering a safety-first culture.
Adhering to all SOPs, Work Instructions, and cGMP regulations, accurately documenting clinical manufacturing activities, and routinely cleaning cleanrooms, manufacturing support areas, and equipment.
Operating and maintaining bench-top equipment, including tubing welders, tube sealers, cell counters, centrifuges, and other cell therapy process systems.
Managing material processes and data entry for manufacturing metrics, participating in material management and bill of material activities, leading small manufacturing projects, and acting as a subject matter expert for minor equipment.