Production Specialist III Cell Therapy Cell Culture

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, CT-MOD, you will be responsible for clinical manufacturing of novel cell therapy drug substance within the Cell Therapy Module (CT-MOD). You will collaborate closely with Biological Development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensure platform alignment.

Your Tasks and Responsibilities:

• Perform clinical manufacturing operations across Solution Preparation, Cell Expansion, Cell Culture, and Final Fill and freezing.
• Participate in new product introductions into CT-MOD with BD and MSAT support.
• Manufacture products across multiple phases of the product life cycle from clinical through launch.
• Handle and troubleshoot single-use technology, monitor and control processes using data trending and/or statistical process control.
• Author, redline, and review controlled documents for equipment and processes.
• Create, own, and drive business processes of moderate complexity in CT-MOD.
• Perform commissioning and IOPQ of CT-MOD equipment and execute C&Q documentation under supervision.
• Support development of training curricula and materials for the CT-MOD team.

Who You Are:

• Bachelor's degree in Biotechnology, Biology, Biochemistry, Chemical Engineering, or a related field.
• 4–6 years of cGMP biologics or cell therapy manufacturing experience.
• Proficiency with single-use technology systems.
• Working knowledge of phase-appropriate cGMP practices and documentation.
• Experience monitoring and controlling processes using data trending and/or statistical process control.
• Demonstrated ability to author, redline, and review controlled documents and SOPs for equipment and processes.

Preferred Qualifications:

• Master's degree in Biotechnology, Biology, Biochemistry, Chemical Engineering, or a related discipline.
• 6+ years of cGMP experience in cell therapy, gene therapy, or biologics manufacturing.
• Direct experience in a clinical cell therapy environment.
• Hands-on experience with end-to-end cell therapy processes.
• Experience leading or acting as a subject matter expert in regulatory inspections and internal audits.

Salary and Benefits:

• Salary range: $77,760.00 to $116,640.00.
• Additional compensation may include a bonus or incentive compensation.
• Benefits include health care, vision, dental, retirement, PTO, sick leave, etc.