Cell Therapy Production Specialist II — GMP Manufacturing

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

Job summary

Bayer is seeking a Production Specialist II Cell Therapy Cell Culture in Berkeley, CA. You will manufacture clinical cell therapy drug substance in the CT‑MOD, collaborating with BD and MSAT to support new products and ensure platform alignment.

Responsibilities include operating across culture steps, data-driven process control, deviations investigations, and creating/maintaining documentation. The role requires cGMP experience, automation/troubleshooting skills, and ability to train others

Qualifications

• Bachelor’s degree in a science-related field with 2+ years of pharma/biotech manufacturing operations experience, or Master’s degree (or equivalent combination of education and experience)
• Practical knowledge of aseptic techniques and cleanroom operations in a cGMP environment
• Strong understanding of data integrity and regulatory expectations (FDA, EMA) and documentation requirements
• Ability to troubleshoot equipment and processes independently and provide timely decisions during campaigns
• Proficiency with MS Office for data review and documentation
• Effective oral and written communication; ability to train others and work across shifts
• Flexibility to support changing schedules and lift up to 45 lb

Responsibilities

• Operate and execute clinical manufacturing across Solution Preparation, Cell Expansion, Cell Culture, and Final Fill & freezing; maintain cleanroom practices and routine analytics
• Support NPIs with BD and MSAT ensuring schedule and platform alignment
• Monitor processes using data trends and SPC; investigate deviations and product impact
• Troubleshoot and maintain single-use technology and equipment; coordinate maintenance
• Author and review controlled documents and assess material/equipment changes
• Perform commissioning, IOPQ/C&Q activities and related documentation
• Deliver training as SME; ensure shift handovers and communicate status across teams
• Drive Lean initiatives and safety; provide off-hour coverage as needed

Skills

Aseptic techniques

Cleanroom operations

Data integrity

Regulatory knowledge

Troubleshooting equipment

MS Office

Communication

Cross-shift collaboration

Physical capability

Education

Bachelor’s degree in science-related field

Master’s degree or equivalent

Tools

Single-use technologies

Lean manufacturing

Documentation systems

Job description

Bayer is seeking a Production Specialist II Cell Therapy Cell Culture in Berkeley, CA. You will manufacture clinical cell therapy drug substance in the CT‑MOD, collaborating with BD and MSAT to support new products and ensure platform alignment.

Responsibilities include operating across culture steps, data-driven process control, deviations investigations, and creating/maintaining documentation. The role requires cGMP experience, automation/troubleshooting skills, and ability to train others