Sr. Manager, Media Fill

Thermo Fisher Scientific•Greenville, NC

1d•Onsite

About The Position

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every day to enable our customers to make the world healthier, cleaner, and safer. Join our Greenville, NC site, one of Thermo Fisher’s largest sterile manufacturing facilities supporting pharmaceutical and biotech customers globally. As the Sr Manager, Media Fills and Requalification Program, you will lead the site’s aseptic process simulation (APS) program, ensuring the highest standards of sterility assurance, regulatory compliance, and inspection readiness. The role would also provide oversight of all equipment requalification activities for the site. This role is critical to maintaining safe, compliant production of life-saving medicines for patients around the world.

Requirements

Bachelor’s degree in Chemistry, Biology, Biochemistry, Engineering, or related scientific field (required)
10+ years of experience in pharmaceutical or biotech manufacturing
5+ years of leadership/people management experience
Strong experience in aseptic/sterile manufacturing and media fill (APS) programs
Strong experience in pharmaceutical equipment requalification (i.e. autoclaves, storage units, isolators, CIP/SIP systems)
Demonstrated experience with Annex 1, contamination control strategy (CCS), and cleanroom operations
Experience leading deviation investigations, root cause analysis, and CAPA
Experience supporting regulatory inspections (FDA, EMA) and client audits
Deep expertise in aseptic processing and sterility assurance principles
Strong knowledge of GMP, regulatory expectations, and validation lifecycle
Proven ability to lead complex investigations and drive sustainable quality improvements
Strong leadership, communication, and stakeholder management skills
Ability to influence cross-functional teams in a matrixed manufacturing environment

Nice To Haves

Advanced degree (MS or PhD) preferred
Experience in a CDMO or client-facing environment strongly preferred
Experience with systems such as TrackWise, SAP, or MES preferred

Responsibilities

Lead and own the site-wide media fill (aseptic process simulation) program for sterile manufacturing operations and the equipment requalification program
Ensure compliance with global regulatory expectations (FDA, EMA, Annex 1) and maintain a constant state of inspection readiness
Provide technical leadership for aseptic processing, contamination control strategy (CCS), sterilization and cleanroom operations
Partner closely with Quality, Manufacturing, Engineering, and Validation teams to plan, execute, and continuously improve media fill activities
Lead and oversee investigations into media fill failures, aseptic deviations, and contamination events, including root cause analysis and CAPA execution
Serve as the site Subject Matter Expert (SME) during client visits, audits, and regulatory inspections
Drive continuous improvement initiatives to enhance sterility assurance, operational efficiency, and right-first-time execution
Ensure all manufacturing processes, equipment, and documentation adhere to GMP requirements, including SOPs, batch records, and validation standards
Build and develop a high-performing team, fostering a culture of quality, accountability, and continuous improvement
Define and plan resource needs (headcount, capital, and technology) to support current and future sterile manufacturing demands