Production Specialist II Cell Therapy Cell Culture - Berkeley, CA

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

Job summary

Bayer in Berkeley, CA is seeking a Production Specialist II Cell Therapy Cell Culture to join the Pharmaceuticals division. You will manufacture clinical cell therapy products, collaborate with BD and MSAT to align platforms, and support new product introductions while maintaining rigorous cGMP documentation and process controls.

The role emphasizes aseptic operation, data-driven decision making, and cross‑functional teamwork across shifts.

Qualifications

• Bachelor’s degree in a science‑related field with 2+ years of pharma/biotech manufacturing experience or Master’s degree.
• Knowledge of aseptic techniques and cleanroom operations in cGMP environments.
• Experience with data integrity and regulatory expectations (FDA/EMA).
• Ability to troubleshoot equipment and processes and make timely technical decisions.
• Proficiency with MS Office for data review and documentation.
• Strong written and oral communication; able to train others and work across shifts.
• Ability to lift up to 45 lb and support off‑hour coverage when needed.

Responsibilities

• Operate clinical manufacturing across Cell Therapy processes with cleanroom practices.
• Support NPIs with BD and MSAT; ensure schedule alignment.
• Monitor processes with data trending and SPC; investigate deviations.
• Troubleshoot and maintain single‑use tech and equipment; coordinate repairs.
• Author and review controlled documents; assess material/equipment change impact.
• Perform commissioning, IOPQ/CQ activities and related documentation.
• Deliver training as SME; ensure effective shift handovers.
• Drive continuous improvement and Lean initiatives; promote safety and on‑call coverage.

Skills

Aseptic techniques

Data integrity awareness

MS Office

Communication skills

Lean basics

Regulatory familiarity

Education

Bachelor’s degree in science or related field

Master’s degree (or equivalent)

Job description

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.

To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans.

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

Equal Opportunity Employer Statement: Notice for U.S. Visitors: All information on this site is subject to compliance with local rule and regulations as they may vary from time to time and across different geographies, including, without limitation, U.S. Executive Orders.

Bayer is an E-Verify Employer.

Location:

United States : California : Berkeley

Division:

Pharmaceuticals

Reference Code:

881883

Contact Us

Email: [e-mail]