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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.

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.

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…