Senior Cell Therapy Manufacturing Specialist

American Society of Gene & Cell Therapy; Berkeley, Northern (CA, KY); Hybrid; USD 78,000 - 117,000; Full time

Job summary

Bayer is seeking a Production Specialist III for the CT‑MOD Cell Therapy Manufacturing team in Berkeley, CA. The role spans clinical to launch manufacturing with cross‑functional collaboration across BD, MSAT, and QA to ensure aligned processes and robust documentation.

Responsibilities include executing cell culture, expansion, fill/finish, and final QC steps, plus authoring and reviewing SOPs, deviations, CAPAs, and training curricula.

Qualifications

• Bachelor’s degree required in biotech-related field.
• 4–6 years of cGMP biologics or cell therapy manufacturing experience.
• Proficiency with single‑use technology systems.
• Working knowledge of cGMP practices and documentation from clinical through launch.
• Experience with data trending/ SPC and investigations.
• Ability to author, redline, and review SOPs and documentation.
• Experience with deviations and CAPA.
• Familiarity with commissioning and qualification activities (IOPQ/C&Q).
• Cross‑functional collaboration with Development and MSAT.

Responsibilities

• Perform clinical manufacturing operations across Solution Preparation, Cell Expansion, Cell Culture, and Final Fill/Freezing.
• Participate in new product introductions into CT‑MOD with BD and MSAT.
• Manufacture products across clinical through launch and document phase‑appropriate changes.
• Handle single‑use technology, monitor processes, and support investigations.
• Author, redline, and review controlled documents and SOPs.
• Drive CT‑MOD business processes for operational readiness.
• Support commissioning, IOPQ, C&Q and regulatory audits.
• Develop training materials and deliver CT‑MOD training.

Skills

Single‑use tech systems

Cross‑functional collaboration

Communication skills

Data trending / SPC

Documentation & SOPs

Education

Bachelor’s degree in Biotechnology/Biology/Chemical Engineering

Master’s degree in Biotechnology/Biology/Chemical Engineering

Tools

JMP

Minitab

Spotfire

Electronic Batch Records (EBR)

MES

Job description

Bayer is seeking a Production Specialist III for the CT‑MOD Cell Therapy Manufacturing team in Berkeley, CA. The role spans clinical to launch manufacturing with cross‑functional collaboration across BD, MSAT, and QA to ensure aligned processes and robust documentation.

Responsibilities include executing cell culture, expansion, fill/finish, and final QC steps, plus authoring and reviewing SOPs, deviations, CAPAs, and training curricula.