Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (
GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Discover Impactful Work:
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.
A Day in the Life:
- 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
What to Expect:
- Leadership role at a large-scale sterile manufacturing site with global impact
- High visibility supporting regulatory inspections and client partnerships
- Opportunity to shape and enhance aseptic processing and contamination control strategies
- Collaborative, fast-paced environment focused on quality, compliance, and patient safety
Keys to Success:
Education
- Bachelor’s degree in Chemistry, Biology, Biochemistry, Engineering, or related scientific field (required)
- Advanced degree (MS or PhD) preferred
Experience
- 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
- Experience in a CDMO or client-facing environment strongly preferred
Knowledge, Skills, Abilities
- 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
- Experience with systems such as TrackWise, SAP, or MES preferred
Competencies:
- Leadership & Talent Development
- Quality & Compliance Mindset
- Problem Solving & Root Cause Analysis
- Operational Excellence
- Collaboration & Influencing
- Continuous Improvement
Physical Requirements:
Position requires the ability to work in both office and GMP manufacturing environments, including cleanrooms requiring gowning. May involve standing for extended periods, working in classified areas, and lifting up to 35 pounds. Requires manual dexterity, visual acuity, and ability to operate standard equipment and computers.
Additional Information:
- Location: Greenville, NC
- Relocation assistance upon approval
- Must be legally authorized to work in the United States without sponsorship
- Must be able to pass a comprehensive background check and drug screening