Production Specialist III Cell Therapy Cell Culture

The Production Specialist III, CT-MOD, is responsible for clinical manufacturing of novel cell therapy drug substance within the Cell Therapy Module (CT-MOD). The role involves collaborating closely with Biological Development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensuring platform alignment. The incumbent will contribute to bringing transformative cell therapies to patients by operating at the interface of development and GMP manufacturing within a highly cross-functional, science-driven environment.

What You Will Do

The primary responsibilities of this role are to perform clinical manufacturing operations across Solution Preparation, Cell Expansion, Cell Culture, and Final Fill and freezing. The incumbent will participate in new product introductions into CT-MOD with BD and MSAT support, manufacture products across multiple phases of the product life cycle, and handle and troubleshoot single-use technology.

Why It Might Be a Fit

Bayer seeks an incumbent who possesses a strong understanding of cGMP practices and documentation, experience with single-use technology systems, and excellent oral, written, and presentation communication skills. The ideal candidate will have a proven ability to create, own, and drive business processes of moderate complexity to achieve operational readiness.

Requirements

• 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
• Experience supporting deviations, conducting root cause analyses, and implementing effective CAPA to prevent recurrence
• Familiarity with commissioning and qualification activities, including IOPQ and executing C&Q documentation under supervision
• Strong cross-functional collaboration skills
• Excellent oral, written, and presentation communication skills
• Proven ability to create, own, and drive business processes of moderate complexity to achieve operational readiness

Benefits

• health care
• vision
• dental
• retirement
• PTO
• sick leave