Senior Cell Therapy Manufacturing Specialist, CT-MOD

Bayer (Schweiz) AG; Berkeley, Northern (CA, KY); Hybrid; USD 78,000 - 117,000; Full time

Benefits offered by this job

Health care

Vision

Dental

Retirement

PTO

Sick leave

Job summary

Bayer in Berkeley, CA is seeking a Production Specialist III CT-MOD – Cell Therapy Manufacturing to help manufacture clinical cell therapy drug substances. You will perform operations across Solution Preparation, Cell Expansion, Cell Culture, and Final Fill, coordinating with BD and MSAT for new product introductions and ensuring platform alignment.

The role requires a Bachelor’s in biotechnology/biology/biochemistry/chemical engineering and 4–6 years of cGMP biologics or cell therapy

Qualifications

• Bachelor’s degree in Biotech/biology/biochemistry/engineer or related field.
• 4–6 years of cGMP biologics or cell therapy manufacturing experience with hands-on work in solution preparation, cell expansion/culture, and aseptic fill/finish.
• Proficiency with single-use technology systems, including setup, operation, and troubleshooting.
• Working knowledge of phase-appropriate cGMP practices and documentation from clinical through launch.
• Experience monitoring and controlling processes using data trending and/or statistical process control, with ability to elevate issues.
• Experience authoring, redlining, and reviewing controlled documents and SOPs.
• Experience supporting deviations, root cause analyses, and CAPA.
• Familiarity with commissioning and qualification activities, including IOPQ and C&Q documentation.
• Cross-functional collaboration with Development and MSAT.
• Excellent communication skills and ability to transfer knowledge across shifts and leadership.
• Commitment to safety and willingness to work across CT-MOD areas and shifts.

Responsibilities

• Perform clinical manufacturing operations across Solution Preparation, Cell Expansion, Cell Culture, and Final Fill and freezing.
• Participate in new product introductions into CT-MOD with BD and MSAT support.
• Manufacture products across multiple phases from clinical through launch and document phase-appropriate differences.
• Handle and troubleshoot single-use technology, monitor processes, and investigate issues.
• Author and review documentation for equipment and processes.
• Create, own, and drive CT-MOD business processes and support deviation investigations.
• Perform commissioning and IOPQ of CT-MOD equipment and support audits and safety investigations.
• Develop training curricula and materials; deliver training and drive continuous improvement.

Education

Bachelor’s degree in Biotechnology, Biology, Biochemistry, Chemical Engineering, or a related field

Job description

Bayer in Berkeley, CA is seeking a Production Specialist III CT-MOD – Cell Therapy Manufacturing to help manufacture clinical cell therapy drug substances. You will perform operations across Solution Preparation, Cell Expansion, Cell Culture, and Final Fill, coordinating with BD and MSAT for new product introductions and ensuring platform alignment.

The role requires a Bachelor’s in biotechnology/biology/biochemistry/chemical engineering and 4–6 years of cGMP biologics or cell therapy