Senior Cell Therapy Manufacturing Specialist

Biopharma Careers; Berkeley (CA); On-site; USD 78,000 - 117,000; Full time

Job summary

Bayer is seeking a Production Specialist III for Cell Therapy Manufacturing in Berkeley, CA to lead manufacturing operations across cell culture and fill/finish processes. You will drive process control, documentation, and cross-functional collaboration with MSAT and Development teams.

You will author and review SOPs, support deviations and CAPA, and contribute to training and continuous improvement initiatives while ensuring safety and regulatory compliance.

Qualifications

• Bachelor's degree in Biotechnology, Biology, Biochemistry, Chemical Engineering, or 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 escalation 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.

Responsibilities

• Perform clinical manufacturing operations across Solution Preparation, Cell Expansion, Cell Culture, and Final Fill and freezing...
• Participate in new product introductions into CT-MOD with BD and MSAT support, ensuring activities are performed according to schedule...
• Manufacture products across multiple phases of the product life cycle from clinical through launch and clearly communicate phase-appropriate differences...
• Handle and troubleshoot single-use technology, monitor and control processes using data trending and/or SPC, and work cross-functionally to ensure process control...
• Author, redline, and review controlled documents for equipment and processes, ensure alignment with cell therapy platform philosophy...
• Create, own, and drive business processes of moderate complexity in CT-MOD to ensure operational readiness and efficient manufacturing...
• 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...
• Support development of training curricula and materials for the CT-MOD team, deliver training as a subject matter expert, maintain personal training compliance...

Skills

cGMP biologics

Cell therapy manufacturing

Single-use technology

Documentation & SOPs

Data trending / SPC

Cross-functional collaboration

Safety adherence

Education

Bachelor's degree in Biotechnology or related field

Master's degree (preferred)

Tools

Electronic Batch Records (EBR)

MES systems

Automation platforms

CQV/IOPQ documentation

Job description

Bayer is seeking a Production Specialist III for Cell Therapy Manufacturing in Berkeley, CA to lead manufacturing operations across cell culture and fill/finish processes. You will drive process control, documentation, and cross-functional collaboration with MSAT and Development teams.

You will author and review SOPs, support deviations and CAPA, and contribute to training and continuous improvement initiatives while ensuring safety and regulatory compliance.