Production Specialist III Cell Therapy Cell Culture - Berkeley, CA (Berkeley, California, US)

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Production Specialist III Cell Therapy Cell Culture - Berkeley, CA

Production Specialist III, CT-MOD – Cell Therapy Manufacturing

Responsible for clinical manufacturing of novel cell therapy drug substance within the Cell Therapy Module (CT-MOD); collaborate closely with Biological Development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensure platform alignment; contribute to bringing transformative cell therapies to patients by operating at the interface of development and GMP manufacturing within a highly cross-functional, science-driven environment.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Production Specialist III, CT-MOD, are to:

Perform clinical manufacturing operations across Solution Preparation, Cell Expansion, Cell Culture, and Final Fill and freezing, executing seamlessly across all areas and acting as a delegate to the Sr. Production Specialist;

Participate in new product introductions into CT-MOD with BD and MSAT support, ensuring activities are performed according to schedule and aligned with platform processes, equipment, raw materials, and automation for at least one area;

Manufacture products across multiple phases of the product life cycle from clinical through launch and clearly communicate phase-appropriate differences in documentation, sample handling, automation, and cGMP expectations;

Handle and troubleshoot single-use technology, monitor and control processes using data trending and/or statistical process control, and work cross-functionally to ensure process control, escalation, and investigation of issues;

Author, redline, and review controlled documents for equipment and processes, ensure alignment with cell therapy platform philosophy, and assess documentation impact of changes in materials and equipment to provide sound recommendations;

Create, own, and drive business processes of moderate complexity in CT-MOD to ensure operational readiness and efficient manufacturing, including raising and supporting deviation investigations, partnering on root cause and product impact, and implementing effective corrective actions;

Perform commissioning and IOPQ of CT-MOD equipment and execute C&Q documentation under supervision, participate in regulatory and internal audits, and support safety investigations while promoting safe behaviors and implementing corrective actions;

Support development of training curricula and materials for the CT-MOD team, deliver training as a subject matter expert, maintain personal training compliance, and drive a culture of continuous improvement by challenging the status quo, proposing solutions, and encouraging innovation in others.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

Bachelor’s degree in Biotechnology, Biology, Biochemistry, Chemical Engineering, or a related field;

4–6 years of cGMP biologics or cell therapy manufacturing experience with hands-on work in solution preparation, cell expansion/culture, and aseptic fill/finish;

Proficiency with single-use technology systems, including setup, operation, and troubleshooting;

Working knowledge of phase-appropriate cGMP practices and documentation from clinical through launch, including sampling, automation, batch records, and change control;

Experience monitoring and controlling processes using data trending and/or statistical process control, with the ability to escalate issues and support investigations;

Demonstrated ability to author, redline, and review controlled documents and SOPs for equipment and processes;

Experience supporting deviations, conducting root cause analyses, and implementing effective CAPA to prevent recurrence;

Familiarity with commissioning and qualification activities, including IOPQ and executing C&Q documentation under supervision;

Strong cross-functional collaboration skills partnering with Development and MSAT to align on process, equipment, materials, and automation;

Excellent oral, written, and presentation communication skills to ensure effective knowledge transfer across shifts and to leadership;

Proven ability to create, own, and drive business processes of moderate complexity to achieve operational readiness;

Demonstrated commitment to safety, including participation in safety investigations and regulatory/internal audits;

Willingness to work across CT-MOD areas and shifts as business needs require.

Preferred Qualifications:

Master’s degree in Biotechnology, Biology, Biochemistry, Chemical Engineering, or a related discipline;

6+ years of cGMP experience in cell therapy, gene therapy, or biologics manufacturing, including late-stage and launch products;

Direct experience in a clinical cell therapy environment (e.g., autologous or allogeneic cell therapies) using single-use technologies;

Hands-on experience with end-to-end cell therapy processes, including cell expansion, differentiation, and fill/finish for a single cell line or platform;

Experience leading or acting as a subject matter expert in regulatory inspections and internal audits;

Advanced experience with statistical process control tools and data analytics (e.g., JMP, Minitab, Spotfire, or similar);

Demonstrated experience driving continuous improvement or operational excellence initiatives (e.g., Lean, Six Sigma, Kaizen);

Prior experience mentoring or training operators or associates and developing training curricula or materials;

Experience with electronic batch records (EBR), MES, and automation platforms commonly used in cell therapy manufacturing;

Familiarity with commissioning, qualification, and validation (CQV) for cell therapy equipment and single-use systems.

Employees can expect to be paid a salary between $77,760.00 to $116,640.00.  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 9/1/26.

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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: 881881          Contact Us     Email: hrop_usa@bayer.com  ]]>