Cell Therapy Production Specialist II — Culture & Innovation

Bayer; Berkeley (CA); On-site; USD 67,000 - 100,000; Full time

Job summary

Bayer in Berkeley, CA is seeking a Production Specialist II Cell Therapy Cell Culture to join the Pharmaceuticals division. You will manufacture clinical cell therapy products, collaborate with BD and MSAT to align platforms, and support new product introductions while maintaining rigorous cGMP documentation and process controls.

The role emphasizes aseptic operation, data-driven decision making, and cross‑functional teamwork across shifts.

Qualifications

• Bachelor’s degree in a science‑related field with 2+ years of pharma/biotech manufacturing experience or Master’s degree.
• Knowledge of aseptic techniques and cleanroom operations in cGMP environments.
• Experience with data integrity and regulatory expectations (FDA/EMA).
• Ability to troubleshoot equipment and processes and make timely technical decisions.
• Proficiency with MS Office for data review and documentation.
• Strong written and oral communication; able to train others and work across shifts.
• Ability to lift up to 45 lb and support off‑hour coverage when needed.

Responsibilities

• Operate clinical manufacturing across Cell Therapy processes with cleanroom practices.
• Support NPIs with BD and MSAT; ensure schedule alignment.
• Monitor processes with data trending and SPC; investigate deviations.
• Troubleshoot and maintain single‑use tech and equipment; coordinate repairs.
• Author and review controlled documents; assess material/equipment change impact.
• Perform commissioning, IOPQ/CQ activities and related documentation.
• Deliver training as SME; ensure effective shift handovers.
• Drive continuous improvement and Lean initiatives; promote safety and on‑call coverage.

Skills

Aseptic techniques

Data integrity awareness

MS Office

Communication skills

Lean basics

Regulatory familiarity

Education

Bachelor’s degree in science or related field

Master’s degree (or equivalent)

Job description

Bayer in Berkeley, CA is seeking a Production Specialist II Cell Therapy Cell Culture to join the Pharmaceuticals division. You will manufacture clinical cell therapy products, collaborate with BD and MSAT to align platforms, and support new product introductions while maintaining rigorous cGMP documentation and process controls.

The role emphasizes aseptic operation, data-driven decision making, and cross‑functional teamwork across shifts.