Production Specialist III Cell Therapy Cell Culture Berkeley, CA

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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:

• Bachelors degree in Biotechnology Biology Biochemistry Chemical Engineering or a related field;
• 46 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.

• Masters 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 $77760.00 to $116640.00. 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 applicants location market data/ranges an applicants 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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