Job Description

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, No contact lens allowed; prescriptive glasses will be provided, 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.

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 Technical Manager, Operations, 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.

Job Tags

Remote job, Full time, Work at office, Immediate start, Monday to Friday

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