Cell Therapy Manufacturing Specialist, CT-MOD

Bayer AG; Berkeley (CA); On-site; USD 78,000 - 117,000; Full time

Job summary

Bayer AG in Berkeley, CA is seeking a Production Specialist III for CT-MOD cell therapy manufacturing. The role involves clinical-scale production across solution prep, cell expansion, culture, and fill/finish, with close collaboration with BD and MSAT to implement new products and ensure GMP compliance.

You will operate in a cross-functional setting, handling deviations, CAPAs, and training while maintaining safety and documentation standards.

Qualifications

• Bachelor’s degree in Biotechnology, Biology, Biochemistry, Chemical Engineering, or related field.
• 4–6 years of cGMP biologics or cell therapy manufacturing experience with hands-on work in solution prep, 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.
• Ability to author, redline, and review controlled documents and SOPs for equipment and processes.

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, ensuring activities align with platform processes and schedule.
• Manufacture products across multiple phases of the product life cycle from clinical through launch and document differences in data and procedures.
• Handle single-use technology, monitor processes, and work cross-functionally to ensure process control and investigations.
• Author and review documents for equipment and processes, assess impact of changes to materials and equipment.

Skills

Data analysis

Process control

Troubleshooting

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree in Biotechnology

Tools

Single-use systems

Job description

Bayer AG in Berkeley, CA is seeking a Production Specialist III for CT-MOD cell therapy manufacturing. The role involves clinical-scale production across solution prep, cell expansion, culture, and fill/finish, with close collaboration with BD and MSAT to implement new products and ensure GMP compliance.

You will operate in a cross-functional setting, handling deviations, CAPAs, and training while maintaining safety and documentation standards.