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 ourGreenville, NC site, one of Thermo Fisher’s largest sterile manufacturing facilities supporting pharmaceutical and biotech customers globally. As theSr 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 thesite-wide media fill (aseptic process simulation) programfor sterile manufacturing operations and the equipment requalification program
- Ensure compliance withglobal regulatory expectations (FDA, EMA, Annex 1)and maintain a constant state of inspection readiness
- Provide technical leadership foraseptic processing, contamination control strategy (CCS), sterilization and cleanroom operations
- Partner closely withQuality, Manufacturing, Engineering, and Validationteams to plan, execute, and continuously improve media fill activities
- Lead and oversee investigations intomedia fill failures, aseptic deviations, and contamination events, including root cause analysis and CAPA execution
- Serve as thesite Subject Matter Expert (SME)during client visits, audits, and regulatory inspections
- Drive continuous improvement initiatives to enhancesterility assurance, operational efficiency, and right-first-time execution
- Ensure all manufacturing processes, equipment, and documentation adhere toGMP requirements, including SOPs, batch records, and validation standards
- Build and develop a high-performing team, fostering a culture ofquality, accountability, and continuous improvement
- Define and planresource needs (headcount, capital, and technology)to support current and future sterile manufacturing demands
What to Expect:
- Leadership role at alarge-scale sterile manufacturing site with global impact
- High visibility supportingregulatory inspections and client partnerships
- Opportunity to shape and enhanceaseptic processing and contamination control strategies
- Collaborative, fast-paced environment focused onquality, 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 inaseptic/sterile manufacturing and media fill (APS) programs
- Strong experience in pharmaceutical equipment requalification (i.e. autoclaves, storage units, isolators, CIP/SIP systems)
- Demonstrated experience withAnnex 1, contamination control strategy (CCS), and cleanroom operations
- Experience leadingdeviation investigations, root cause analysis, and CAPA
- Experience supportingregulatory inspections (FDA, EMA) and client audits
- Experience in aCDMO or client-facing environmentstrongly preferred
Knowledge, Skills, Abilities
- Deep expertise inaseptic processing and sterility assurance principles
- Strong knowledge ofGMP, regulatory expectations, and validation lifecycle
- Proven ability to leadcomplex investigations and drive sustainable quality improvements
- Strong leadership, communication, and stakeholder management skills
- Ability to influence cross-functional teams in amatrixed manufacturing environment
- Experience with systems such asTrackWise, SAP, or MESpreferred
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 andGMP 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
