Senior Cell Therapy Manufacturing SME – Flexible Hours

Biopharma Careers; Berkeley (CA); On-site; USD 94,000 - 141,000; Full time

Job summary

Bayer is seeking a Sr. Product Specialist Cell Therapy Cell Culture in Berkeley, CA to lead clinical manufacturing within the CTMOD, act as SME for cell culture operations, and collaborate with BD and MSAT to ensure platform alignment and compliant, scalable processes delivering innovative cell therapies to patients.

The role requires 5–7 years in cell therapy or biologics with mammalian culture and cGMP experience, plus NPIs/tech transfer, strong documentation and audit skills, and willingness

Qualifications

• Bachelor’s degree in life science or engineering; advanced degree preferred.
• 5–7 years of cell therapy/biologics manufacturing experience.
• Hands-on mammalian cell culture and aseptic processing in cGMP.
• Experience with NPIs and technology transfer to manufacturing.
• Strong documentation and audit readiness.

Responsibilities

• Manufacture products across clinical to launch phases while adhering to cGMP.
• Serve as SME for CTMOD cell culture operations and cross‑functional collaboration.
• Develop training materials and ensure ongoing compliance.
• Support deviations investigations, CAPAs and safety actions.
• Lead audits and participate in regulatory inspections.

Skills

Cell Culture

cGMP Compliance

Data Analysis

NPIs/Tech Transfer

SUT

Documentation

Audits

Education

Bachelor’s degree in life science or engineering

Advanced degree (MS/PhD)

Tools

MES

LIMS

Electronic Batch Records

Job description

Bayer is seeking a Sr. Product Specialist Cell Therapy Cell Culture in Berkeley, CA to lead clinical manufacturing within the CTMOD, act as SME for cell culture operations, and collaborate with BD and MSAT to ensure platform alignment and compliant, scalable processes delivering innovative cell therapies to patients.

The role requires 5–7 years in cell therapy or biologics with mammalian culture and cGMP experience, plus NPIs/tech transfer, strong documentation and audit skills, and willingness