Production Specialist II Cell Therapy Cell Culture - Berkeley, CA

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

Benefits offered by this job

Health care

Vision

Dental

Retirement plan

PTO

Sick leave

Job summary

Bayer is hiring a Production Specialist II Cell Therapy Cell Culture in Berkeley, CA. You will manufacture clinical cell therapy substrates, collaborating with BD and MSAT to support NPIs and ensure platform alignment.

The role emphasizes aseptic techniques, data integrity, and regulatory compliance, with opportunities to lead process improvements and training across shifts. Salary ranges and comprehensive benefits apply.

Qualifications

• Bachelor’s degree in a science-related field or Master’s degree with pharma/biotech manufacturing experience.
• Aseptic techniques and cleanroom operations in cGMP environments are required.
• Strong understanding of data integrity and regulatory expectations (FDA/EMA).
• Ability to troubleshoot equipment and processes independently.
• Excellent oral and written communication skills; able to train others.
• Flexible to support changing schedules and off-hour coverage; able to lift up to 45 lb.

Responsibilities

• Operate clinical manufacturing across Solution Preparation, Cell Expansion, Cell Culture, Final Fill & freezing.
• Support new product introductions ensuring schedule and platform alignment.
• Monitor processes using data trending and SPC; investigate deviations.
• Troubleshoot and maintain single‑use tech; coordinate maintenance with teams.
• Author and review controlled documents; assess impact of changes.
• Perform commissioning and IOPQ/C&Q activities under supervision.
• Deliver training and ensure effective shift handovers across teams.
• Drive Lean initiatives; promote safety; support shift coverage as needed.

Skills

Aseptic techniques

Cleanroom operations

Data integrity

Regulatory expectations (FDA/EMA)

Troubleshooting equipment

Oral and written communication

Adaptability / off-hour coverage

Safety awareness

Team collaboration

Lift 45 lb

Education

Bachelor’s degree in a science-related field

Master’s degree (or equivalent)

Tools

Microsoft Office

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.

Bayer Equal Opportunity

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is an E-Verify Employer.

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.

Location and Contact

Location: United States : California : Berkeley

Division: Pharmaceuticals

Reference Code: 881883

Email: [e-mail]