Cell Therapy Manufacturing Specialist II — Impact & Growth

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

Benefits offered by this job

Health care

Vision

Dental

Retirement plan

PTO

Sick leave

Job summary

Bayer is hiring a Production Specialist II Cell Therapy Cell Culture in Berkeley, CA. You will manufacture clinical cell therapy substrates, collaborating with BD and MSAT to support NPIs and ensure platform alignment.

The role emphasizes aseptic techniques, data integrity, and regulatory compliance, with opportunities to lead process improvements and training across shifts. Salary ranges and comprehensive benefits apply.

Qualifications

• Bachelor’s degree in a science-related field or Master’s degree with pharma/biotech manufacturing experience.
• Aseptic techniques and cleanroom operations in cGMP environments are required.
• Strong understanding of data integrity and regulatory expectations (FDA/EMA).
• Ability to troubleshoot equipment and processes independently.
• Excellent oral and written communication skills; able to train others.
• Flexible to support changing schedules and off-hour coverage; able to lift up to 45 lb.

Responsibilities

• Operate clinical manufacturing across Solution Preparation, Cell Expansion, Cell Culture, Final Fill & freezing.
• Support new product introductions ensuring schedule and platform alignment.
• Monitor processes using data trending and SPC; investigate deviations.
• Troubleshoot and maintain single‑use tech; coordinate maintenance with teams.
• Author and review controlled documents; assess impact of changes.
• Perform commissioning and IOPQ/C&Q activities under supervision.
• Deliver training and ensure effective shift handovers across teams.
• Drive Lean initiatives; promote safety; support shift coverage as needed.

Skills

Aseptic techniques

Cleanroom operations

Data integrity

Regulatory expectations (FDA/EMA)

Troubleshooting equipment

Oral and written communication

Adaptability / off-hour coverage

Safety awareness

Team collaboration

Lift 45 lb

Education

Bachelor’s degree in a science-related field

Master’s degree (or equivalent)

Tools

Microsoft Office

Job description

Bayer is hiring a Production Specialist II Cell Therapy Cell Culture in Berkeley, CA. You will manufacture clinical cell therapy substrates, collaborating with BD and MSAT to support NPIs and ensure platform alignment.

The role emphasizes aseptic techniques, data integrity, and regulatory compliance, with opportunities to lead process improvements and training across shifts. Salary ranges and comprehensive benefits apply.