Prod Spec III Cell Therapy Cell Culture

Bayer•Berkeley, CA

15h•$77,760 - $116,640•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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.