Prod Spec III Cell Culture Tech Center - Berkeley, CA

At Bayer, we're visionaries driven to solve the world's toughest challenges and strive for a world where 'Health for all, Hunger for none' is a reality.

As a Production Specialist III – Cell Culture Technology Center (CCTC), you'll be responsible for manufacturing monoclonal antibody (mAb) drug substance within the CCTC and Manufacturing Biologics cluster.

Your Tasks and Responsibilities:

• Execute end-to-end manufacturing operations for mAb drug substance across Cell Expansion, Cell Culture, Purification, Solution Preparation, and Weigh/Dispense, acting as a subject matter expert (SME) for at least one area.
• Manufacture products across multiple life-cycle phases, from clinical through launch, managing differences in documentation, sample handling, automation, and cGMP expectations.
• Handle and troubleshoot single-use technology (SUT) throughout the manufacturing process, ensuring reliable and compliant operation of equipment and systems.
• Monitor and control processes using data trending and statistical process control, working cross-functionally to maintain a controlled state and escalate and investigate issues as needed.
• Author, redline, and review controlled documents for equipment and processes, ensuring alignment with CCTC platform philosophy.
• Create, own, and drive business processes of moderate complexity within CCTC to ensure operational readiness and efficient manufacturing.
• Participate in regulatory and internal audits, including leading internal audit walkthroughs, and support commissioning, qualification (IOPQ), and execution of C&Q documentation for CCTC equipment.
• Support development of training curricula and materials, deliver training as an SME, and ensure your own training remains compliant and up to date.
• Identify and drive continuous improvement opportunities, challenge the status quo, and promote safe behaviors.
• Act as a delegate to the Sr. Production Specialist and CCTC Production Manager to support business continuity and leadership coverage.

Who You Are:

• Bachelor's degree with 4+ years of industry experience, or a Master's or PhD with no prior industry experience, preferably in a science-related discipline.
• Demonstrated ability to work with flexibility, adapt to last-minute production schedule changes, and provide off-hour coverage.
• Strong independent thinking and decision-making skills, with the ability to make logical decisions for multiple process workstreams.
• Proven ability to understand and troubleshoot equipment, resolve issues independently, and experience with single-use technologies.
• Experience with data integrity, regulatory, and cGMP requirements for pharmaceutical manufacturing.
• Proficiency with business IT systems and Microsoft Office.

Benefits:

• Salary between $97,000.00 to $125,000.00
• Additional compensation may include a bonus or commission
• Health care, vision, dental, retirement, PTO, sick leave, etc.