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Production Specialist II Cell Therapy Cell Culture - Berkeley, CA 

As a Prod Spec II Cell Therapy Cell Culture, you are responsible for clinical manufacturing of novel cell therapy drug substance within the Cell Therapy Module (CT‑MOD);
You collaborate closely with Biological Development (BD) and Manufacturing Science and Technology (MSAT) to support new product introductions and ensure platform alignment;

YOUR TASKS AND RESPONSIBILITIES

• Operate and execute clinical manufacturing across Solution Preparation, Cell Expansion, Cell Culture, and Final Fill & freezing, including product changeovers, cleanroom practices and routine analytics;
• Support new product introductions (NPIs) with BD and MSAT, ensuring activities meet schedule and platform alignment;
• Monitor and control processes using data trending and statistical process control, escalate and support investigations into deviations and product impact;
• Troubleshoot and maintain single‑use technology and equipment, coordinate maintenance and repairs with technical teams;
• Author, redline and review controlled documents, assess documentation impact of material or equipment changes and support change decisions;
• Perform commissioning, IOPQ/C&Q activities and execute related documentation under supervision;
• Deliver training as a subject‑matter expert, ensure effective shift handovers, and communicate operational status across teams;
• Drive continuous improvement and Lean initiatives, promote safety and respond flexibly to shift and off‑hour coverage needs.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Bachelor’s degree in a science‑related field with 2+ years of relevant pharmaceutical/biotech manufacturing operations experience, or Master’s degree (or equivalent combination of education and experience);
• Practical knowledge of aseptic techniques and cleanroom operations, and experience working within cGMP environments;
• Strong understanding of data integrity, regulatory expectations (FDA, EMA, etc.), and pharmaceutical manufacturing documentation requirements;
• Demonstrated ability to troubleshoot equipment and process issues independently and provide timely technical decisions during campaigns;
• Proficiency with business IT systems and Microsoft Office for data review, documentation and communication;
• Effective oral and written communication skills, ability to train others and work collaboratively across shifts and functions;
• Flexibility to support changing schedules and provide off‑hour coverage when needed, and ability to lift up to 45 lb.

Preferred Qualifications:

• Direct experience in cell therapy manufacturing, single‑use technologies, or working with pluripotent stem cell expansion and differentiation;
• Experience with Lean manufacturing methods and continuous improvement projects.