Production Specialist II Cell Therapy Cell Culture - Berkeley, CA

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

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At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

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, elevate 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.

Employees can expect to be paid a salary between $66,560.00 - $99,840.00. Additional compensation may include a bonus or incentive compensation (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc..

This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

This posting will be available for application until at least 9/4/26.

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Bayer offers a wide variety of competitive compensation and benefits programs.

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Bayer is an Equal Opportunity Employer/Disabled/Veterans

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