Senior Cell Therapy Production Specialist – Culture & GMP

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

Benefits offered by this job

Health care

Vision

Dental

Retirement

PTO

Sick leave

Job summary

Bayer in Berkeley, CA, is seeking a Production Specialist II Cell Therapy Cell Culture to perform clinical manufacturing across cell culture processes. The role collaborates with BD and MSAT to introduce new products and ensure platform alignment, while maintaining GMP and data integrity.

You will support product changes, document control, and continuous improvement, with training duties and potential off-hour coverage as needed. Compensation reflects market norms for the region.

Qualifications

• Bachelor’s degree in a science-related field with 2+ years pharma/biotech manufacturing experience.
• Experience with aseptic techniques and cleanroom operations in cGMP environments.
• Strong data integrity knowledge and regulatory expectations (FDA, EMA).
• Ability to troubleshoot equipment and make timely decisions during campaigns.
• Proficiency with business IT systems and MS Office for data review and communication.
• Effective oral and written communication skills, able to train others and work across shifts.

Responsibilities

• Operate and execute clinical manufacturing across Solution Preparation, Cell Expansion, Cell Culture, and Final Fill & freezing.
• Support NPIs with BD and MSAT, ensuring schedule and platform alignment.
• Monitor processes using data trending and SPC; escalate deviations and investigations.
• Troubleshoot and maintain single-use technology and equipment, coordinate maintenance with technical teams.
• Author, redline and review controlled documents; assess documentation impact of changes.
• Perform commissioning, IOPQ/C&Q activities and related documentation under supervision.
• Deliver training as SME, ensure shift handovers, communicate status across teams.
• Drive continuous improvement and Lean initiatives; support safety and off-hour coverage.

Skills

Aseptic techniques

Cleanroom operations

Data integrity

Regulatory expectations

Troubleshooting

MS Office

Communication skills

Flexibility

Heavy lifting

Education

Bachelor’s degree in a science field

Master’s degree or equivalent

Job description

Bayer in Berkeley, CA, is seeking a Production Specialist II Cell Therapy Cell Culture to perform clinical manufacturing across cell culture processes. The role collaborates with BD and MSAT to introduce new products and ensure platform alignment, while maintaining GMP and data integrity.

You will support product changes, document control, and continuous improvement, with training duties and potential off-hour coverage as needed. Compensation reflects market norms for the region.