Prod Spec III Cell Culture Tech Center - Berkeley, CA

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

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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.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Production Specialist III – CCTC, are to:

• 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 upscale 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.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• 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.

Preferred Qualifications:

• 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.

Employees can expect to be paid a salary between $97,000.00 to $125,000.00. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.

This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

This posting will be available for application until at least 10-19-2026.

YOUR APPLICATION

To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

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