Manager, Formulations, IA & Biologicals

at  Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is seeking a highly motivated and experienced Manager, Formulations, IA & Biologicals to join our world-class team in Middletown, MD, USA. As the Formulation Manufacturing Manager, you will play a critical role in leading cGMP manufacturing activities for Immunoassays and Biologicals. You will be responsible for ensuring that our IA and biological formulations meet operational goals in safety, quality, delivery, and productivity. This is an exceptional opportunity to contribute to the development and manufacturing of materials for clinical trials and commercial use.

• Lead cGMP manufacturing activities for IA and biological formulations
• Collaborate with cross-functional teams to achieve production goals and timelines
• Review and approve batch records, change controls, and project plans
• Develop, review, and approve SOP’s and Work Instructions
• Support investigations and drive root cause/corrective action culture
• Coordinate manufacturing activities and supervise personnel
• Promote a positive and proactive work environment to sustain strong employee engagement levels
• Develop employees and provide feedback and coaching for performance improvement
• Drive innovation and continuous improvement activities to enhance compliance with quality procedures
• Other relevant responsibilitie