Senior Cell Therapy Manufacturing Specialist

Bayer; Berkeley (CA); On-site; 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, seeks a Production Specialist III CT-MOD to manufacture clinical cell therapy products and partner with BD and MSAT for new product introductions, ensuring GMP compliance across solution prep, expansion, culture, and fill/finish.

The role requires a bachelor’s in biotech or related field and 4–6 years of cGMP biologics/cell therapy experience, with strong documentation, cross‑functional collaboration, and hands‑on experience with single‑use systems.

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 from clinical through launch.
• Experience monitoring and controlling processes using data trending and/or statistical process control.
• Experience authoring, redlining, and reviewing controlled documents and SOPs.

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 accordingly.
• Handle and troubleshoot single-use technology and monitor processes with data trends.
• Author and review SOPs and change controls; assess impact of material/equipment changes.
• Develop and maintain training curricula; deliver training and promote continuous improvement.

Skills

cGMP Biologics

Cell culture

Single-use tech

Documentation

Data trending

Cross-functional

Quality systems

Education

Bachelor’s degree in Biotechnology

Master’s degree in Biotechnology

Tools

JMP

Minitab

Spotfire

EBR

MES

Job description

Bayer in Berkeley, CA, seeks a Production Specialist III CT-MOD to manufacture clinical cell therapy products and partner with BD and MSAT for new product introductions, ensuring GMP compliance across solution prep, expansion, culture, and fill/finish.

The role requires a bachelor’s in biotech or related field and 4–6 years of cGMP biologics/cell therapy experience, with strong documentation, cross‑functional collaboration, and hands‑on experience with single‑use systems.