Prod Spec III Cell Culture Tech Center - Berkeley, CA

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ‘Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us.

If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Responsible for manufacturing monoclonal antibody (mAb) drug substance within the Cell Culture Technology Center (CCTC) and Manufacturing Biologics cluster, you collaborate closely with the CMC Drug Substance cluster for new product introductions and ensure platform alignment across products and processes;
In this role, you work seamlessly across all manufacturing areas and act as a subject matter expert (SME) for at least one area, helping to drive operational readiness, robust cGMP performance, and continuous improvement within a highly collaborative, science‑driven environment;
By combining hands‑on production expertise with strong cross‑functional partnership, you help ensure that CCTC delivers high‑quality biologics reliably and efficiently in support of Bayer’s mission to bring innovative therapies to patients.

• Execute end‑to‑end manufacturing operations for monoclonal antibody drug substance across Cell Expansion, Cell Culture, Purification, Solution Preparation, and Weigh/Dispense, acting as SME for at least one area;
• Manufacture products across multiple life‑cycle phases, from clinical through launch, clearly managing differences in documentation, sample handling, automation, and cGMP expectations for each phase;
• Handle and troubleshoot single‑use technology (SUT) throughout the manufacturing process, ensuring reliable, compliant operation of equipment and systems;
• Monitor and control processes using data trending and/or 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 and providing recommendations on documentation impacts of material and equipment changes;
• Create, own, and drive business processes of moderate complexity within CCTC to ensure operational readiness and efficient manufacturing, including raising and supporting deviation investigations and implementing effective corrective actions;
• 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 fully compliant and up to date;
• Actively identify and drive continuous improvement opportunities, challenge the status quo, and promote safe behaviors by participating in safety investigations and partnering cross‑functionally on corrective actions;
• Act as delegate to the Sr. Production Specialist and, as needed, to the CCTC Production Manager to support business continuity and leadership coverage.

Bayer seeks an incumbent who possesses the following:

• 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 highest levels of flexibility, including adapting to…