Senior Cell Therapy Manufacturing Specialist

Bayer; Berkeley (CA); On-site; USD 77,000 - 117,000; Full time

Job summary

Bayer in Berkeley, CA is seeking a Production Specialist III CT-MOD to manufacture clinical cell therapy drug substances across solution prep, expansion, culture, and fill/finish, collaborating with BD and MSAT to implement new products.

You will lead documentation, deviations, CAPA, commissioning and QP activities, and contribute to training, safety, and continuous improvement in a cross-functional, GMP environment.

Qualifications

• Bachelor’s degree in Biotechnology, Biology, Biochemistry, Chemical Engineering, or related field.
• 4–6 years of cGMP biologics or cell therapy manufacturing experience.
• Proficiency with single‑use technology systems.
• Working knowledge of phase‑appropriate cGMP practices and documentation.
• Experience monitoring and controlling processes using data trending/SPC.
• Ability to author, redline, and review documents and SOPs.
• Experience supporting deviations and CAPA.
• Familiarity with commissioning and qualification activities (IOPQ and C&Q).
• Cross-functional collaboration with Development and MSAT.
• Excellent communication skills.
• Ability to work across CT-MOD areas and shifts.

Responsibilities

• Perform clinical manufacturing operations across Solution Preparation, Cell Expansion, Cell Culture, and Final Fill.
• Assist in new product introductions into CT‑MOD with BD and MSAT support.
• Manufacture across clinical through launch and document differences accordingly.
• Handle and troubleshoot single‑use technology; monitor with data trends.
• Author/review controlled documents; align with CT‑MOD philosophy.
• Drive CT‑MOD business processes; support deviations and CAPA.
• Perform commissioning and IOPQ; assist audits and safety investigations.
• Contribute to training curricula for the CT‑MOD team.

Skills

cGMP manufacturing

Cell therapy

Single-use tech

Documentation

CAPA

Root cause analysis

Data trending

Cross-functional collab

Regulatory audits

Training development

Education

Bachelor’s degree in Biotechnology/Biology/Biochemistry/Chemical Engineering

Master’s degree in Biotechnology/Biology/Biochemistry/Chemical Engineering

Tools

Single-use tech systems

Job description

Bayer in Berkeley, CA is seeking a Production Specialist III CT-MOD to manufacture clinical cell therapy drug substances across solution prep, expansion, culture, and fill/finish, collaborating with BD and MSAT to implement new products.

You will lead documentation, deviations, CAPA, commissioning and QP activities, and contribute to training, safety, and continuous improvement in a cross-functional, GMP environment.