Cell Therapy Production Specialist II — Cell Culture

American Society of Gene & Cell Therapy; Berkeley, Northern (CA, KY); Hybrid; USD 67,000 - 100,000; Full time

Benefits offered by this job

Health care

Vision

Dental

Retirement

PTO

Sick leave

Job summary

Bayer is seeking a Production Specialist II in Berkeley, CA, to perform clinical manufacturing of cell therapy products in the CT-MOD. You will collaborate with BD and MSAT to align platforms and support new product introductions.

The role requires aseptic processing, documentation, and the ability to troubleshoot equipment while maintaining data integrity and regulatory compliance. Expect a collaborative, cross-shift environment with safety-driven practices.

Qualifications

• Bachelor's degree in science and 2+ years in pharma/biotech manufacturing or a Master’s degree with equivalent experience.
• Practical knowledge of aseptic techniques and cleanroom operations in cGMP environments.
• Strong understanding of data integrity and regulatory expectations (FDA, EMA).
• Ability to troubleshoot equipment and make timely technical decisions during campaigns.
• Proficiency with Microsoft Office for data review and documentation.

Responsibilities

• Operate 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; investigate deviations.

Skills

Aseptic techniques

Data integrity

Regulatory knowledge

Troubleshooting equipment

Microsoft Office

Education

Bachelor's degree in science

Master’s degree (or equivalent)

Tools

Data review systems

Job description

Bayer is seeking a Production Specialist II in Berkeley, CA, to perform clinical manufacturing of cell therapy products in the CT-MOD. You will collaborate with BD and MSAT to align platforms and support new product introductions.

The role requires aseptic processing, documentation, and the ability to troubleshoot equipment while maintaining data integrity and regulatory compliance. Expect a collaborative, cross-shift environment with safety-driven practices.