Cell & Gene Therapy Specialist I

Roche • San Diego, CA

3d • Onsite

About The Position

You, as a Cell and Gene Therapy Specialist I, are part of the Genentech San Diego internal manufacturing team in support of Genentech San Diego’s pre-clinical and clinical production of cell therapies. You will support process tech transfers, routine GMP production activities, and technology improvements towards the successful delivery of released product to meet the needs of Genentech San Diego’s clinical trials. The Opportunity Work is generally performed in a GMP manufacturing facility. You are in a position that requires a combination of standing or sitting in a cleanroom manufacturing environment, as well as walking around the facility. You will work in controlled environments requiring special gowning. You are required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body In this role, you are: 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.

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.
• 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
• Demonstrating excellent proficiency in Microsoft Word, Excel, and PowerPoint to support various tasks and projects.
• Showing self-motivation and a positive attitude, with a willingness to take on temporary responsibilities outside the initial job description.
• Adapting to a fast-paced, constantly evolving environment while thinking creatively and proposing innovative solutions.
• Following verbal and written instructions accurately, ensuring effective communication and task execution.
• Applying strong problem-solving skills to address challenges and develop practical solutions.
• Collaborating 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 is a plus

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees