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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.
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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YOUR APPLICATION
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Health for all, Hunger for none, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.
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: hrop_usa@bayer.com