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The Drug Product Division – North America (DPD-NA) is seeking an experienced sterile manufacturing professional to serve as the operational and technical subject matter expert supporting our state-of-the-art sterile fill-finish operations in Greenville, NC.
This is not a traditional desk-based technical role. We are looking for a hands-on operations leader who thrives on the manufacturing floor, enjoys solving complex production challenges, and has a proven track record supporting audits, customer interactions, technical investigations, tech transfers, and continuous improvement initiatives.
As the , you will act as the operational and technical SME across multiple highly automated sterile manufacturing lines. You will partner closely with Manufacturing, Quality, Engineering, MS&T, and Site Leadership to drive operational excellence, improve performance, and ensure reliable execution.
This position does not have direct reports but requires strong leadership, influence, and decision-making across cross-functional teams.
A Day in the Life
In this role, you will:
- Serve as the technical and operational SME for sterile fill-finish manufacturing operations.
- Review daily manufacturing performance and proactively identify operational risks, technical issues, and improvement opportunities.
- Support production teams by troubleshooting complex manufacturing challenges and removing barriers to execution.
- Lead and support investigations, deviations, CAPAs, and root cause analysis activities.
- Drive continuous improvement initiatives focused on reliability, efficiency, throughput, and operational excellence.
- Support customer audits, regulatory inspections, customer tours, and ongoing inspection readiness activities.
- Partner with Quality, Engineering, Manufacturing, and MS&T teams to resolve technical and compliance-related issues.
- Support tech transfer activities, new product introductions, and manufacturing readiness efforts.
- Provide technical leadership during operational issues while helping production teams maintain schedule adherence and product supply.
- Influence cross-functional teams to implement sustainable operational improvements.
Initially, this role will focus heavily on supporting Line 9 and ongoing tech transfer activities while maintaining responsibility across all sterile manufacturing operations within Building 52.
What Makes This Opportunity Unique?
- Brand-new sterile manufacturing facility.
- Three highly automated production lines in startup and growth phases.
- Significant tech transfer activity creating opportunities for impact and visibility.
- Extensive cross-functional collaboration with Operations, Quality, Engineering, MS&T, and Site Leadership.
- High-visibility role supporting customers, audits, inspections, and critical business initiatives.
- Opportunity to shape operational excellence within a rapidly growing manufacturing organization.
- Career growth opportunities within a global pharmaceutical services leader.
Keys to Success
The successful candidate will be:
- Operations-focused and action-oriented.
- Comfortable spending significant time on the manufacturing floor.
- A hands-on problem solver who leads through influence rather than authority.
- Customer-focused and confident interacting directly with clients and auditors.
- Skilled at balancing immediate operational needs with long-term strategic improvements.
- Comfortable navigating ambiguity and driving results in a fast-paced manufacturing environment.
- Known for rolling up their sleeves and solving problems where they occur.
Education
- Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical discipline preferred.
- Equivalent combinations of education, training, and relevant experience will be considered.
Experience
Required
- 8+ years of combined sterile pharmaceutical manufacturing experience with progressive responsibility across operations, technical operations, engineering, quality, or related manufacturing functions.
- Direct sterile fill-finish manufacturing experience.
- Strong operational leadership experience in a GMP manufacturing environment.
- Experience supporting customer audits, regulatory inspections, and inspection readiness activities.
- Experience leading or supporting deviations, investigations, CAPAs, and root cause analysis activities.
- Experience working directly with manufacturing operations and production teams.
- Demonstrated success driving continuous improvement initiatives in pharmaceutical manufacturing environments.
Preferred
- Experience supporting tech transfer activities.
- Experience with isolator technology and aseptic processing.
- Experience supporting highly automated manufacturing lines.
- Previous people leadership experience.
- Experience working across Operations, Engineering, Quality, and Technical Services functions.
Knowledge, Skills & Abilities
- Deep understanding of sterile manufacturing and aseptic processing operations.
- Strong technical troubleshooting and root cause analysis capabilities.
- Working knowledge of cGMP regulations and pharmaceutical manufacturing requirements.
- Strong customer-facing communication skills.
- Ability to support audits, inspections, and regulatory interactions.
- Ability to influence cross-functional stakeholders without direct authority.
- Excellent problem-solving, decision-making, and organizational skills.
- Strong verbal and written communication skills.
Work Environment
- Fully onsite position supporting Building 52 sterile manufacturing operations in Greenville, NC.
- Standard Monday–Friday business hours with flexibility required to support operational needs, audits, inspections, and business-critical activities.