Be Bayer

Production Specialist II Cell Therapy Cell Culture - Berkeley, CA

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'.

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 include:

• 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.

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.