Prod Spec III Cell Culture Tech Center - Berkeley, CA

Bayer•Berkeley, CA

13d•Onsite

About The Position

Responsible for manufacturing monoclonal antibody (mAb) drug substance within the Cell Culture Technology Center (CCTC) and Manufacturing Biologics cluster. This role collaborates closely with the CMC Drug Substance cluster for new product introductions and ensures platform alignment across products and processes. The individual works seamlessly across all manufacturing areas and acts 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, this role helps ensure that CCTC delivers high-quality biologics reliably and efficiently in support of Bayer’s mission to bring innovative therapies to patients.

Requirements

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 last-minute production schedule changes, changing shift schedules based on business needs, and providing off-hour (night and weekend) coverage on short notice.
Strong independent thinking and decision-making skills, with the ability to make logical decisions for multiple process workstreams with limited information or supervision and clearly articulate your decision-making process.
Proven ability to understand and troubleshoot multiple types of equipment, resolving equipment and process-related issues independently, including experience with single-use technologies.
Experience with data integrity, regulatory, and cGMP requirements for pharmaceutical manufacturing, including participation in deviations, investigations, and audits.
Proficiency with business IT systems and Microsoft Office, with excellent overall computer skills.
Ability to lift up to 44 lb and work effectively in a team-oriented, cross-functional environment, demonstrating integrity, accountability, and strong communication skills.

Nice To Haves

Previous experience in technology transfers or new product introductions (NPIs) into manufacturing.
Experience with Lean manufacturing principles and continuous improvement methodologies.
Demonstrated experience acting as a change agent for equipment and processes of moderate complexity, applying effective change management.
Experience mentoring or training others, driving own development, and providing formal and informal feedback to colleagues.

Responsibilities

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.