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 no longer a dream, but a real possibility.

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
• Strong cross-functional collaboration skills
• Excellent oral, written, and presentation communication skills

Benefits:

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