Senior Cell Culture Manufacturing Specialist (mAb)

Bayer AG; Berkeley (CA); On-site; USD 97,000 - 125,000; Full time

Job summary

Bayer is seeking a Production Specialist III – CCTC to manufacture monoclonal antibody drug substance and lead SME activities across cell culture operations. You will work within a science‑driven, collaborative environment to ensure high‑quality biologics and ongoing readiness across manufacturing processes.

The role requires strong cGMP knowledge, data integrity, and the ability to adapt to shifting schedules. Salary ranges reflect US market norms and include potential bonuses and benefits.

Qualifications

• Bachelor’s degree with 4+ years of industry experience, or higher degree with no prior industry experience.
• Willingness to cover off-hour shifts including nights and weekends.
• Strong independent decision-making and ability to manage multiple process workstreams.
• Experience troubleshooting equipment and single-use technologies.
• Experience with data integrity, regulatory, and cGMP requirements.
• Proficiency with Microsoft Office and business IT systems.
• Ability to lift up to 44 lb and work in a cross-functional team.

Responsibilities

• Execute end‑to‑end manufacturing operations for monoclonal antibody drug substance across Cell Expansion, Cell Culture, Purification, Solution Preparation, and Weigh/Dispense, as SME for at least one area.
• Manufacture products across multiple life‑cycle phases, from clinical through launch, managing documentation, sample handling, automation, and cGMP expectations.
• Handle and troubleshoot single‑use technology (SUT) throughout the process to ensure compliant operation.
• Monitor and control processes using data trending and statistical process control with cross‑functional collaboration.
• Author, redline, and review controlled documents for equipment and processes; assess documentation impacts of changes.
• Create, own and drive business processes within CCTC to ensure readiness and efficient manufacturing.
• Participate in regulatory and internal audits and support C&Q documentation for CCTC equipment.
• Assist in training curricula, deliver SME training, and stay compliant.
• Identify and drive continuous improvement and safety actions with cross‑functional partners.
• Act as delegate to Sr. Production Specialist and CCTC Production Manager as needed.

Skills

Data integrity

cGMP compliance

Regulatory audits

Troubleshooting equipment

Single-use technologies

Cross-functional collaboration

Decision making

Shift flexibility

Communication skills

Microsoft Office

Education

Bachelor’s degree with 4+ years experience

Master’s or PhD with no prior industry experience

Tools

SUT systems

Job description

Bayer is seeking a Production Specialist III – CCTC to manufacture monoclonal antibody drug substance and lead SME activities across cell culture operations. You will work within a science‑driven, collaborative environment to ensure high‑quality biologics and ongoing readiness across manufacturing processes.

The role requires strong cGMP knowledge, data integrity, and the ability to adapt to shifting schedules. Salary ranges reflect US market norms and include potential bonuses and benefits.