Director Non-Sterile Operations

ThermoFisher Scientific; Greenville (NC); Vor Ort; USD 180.000 - 230.000; Vollzeit

Zusammenfassung

Thermo Fisher Scientific in Greenville, NC seeks a Director of Non-Sterile Operations to lead and optimize non-sterile manufacturing, packaging, inspection, and device assembly. You will oversee OSD and Continuous Manufacturing platforms, driving safety, quality, and cost performance from development to commercialization.

Responsibilities include ensuring cGMP compliance, guiding technology transfer, and building high‑performing cross-functional teams across packaging, device assembly, and CM

Qualifikationen

• Bachelor’s degree in Engineering, Operations Management, or related field (or equivalent experience).
• 10+ years of progressive operations leadership in pharmaceutical/biopharmaceutical manufacturing, including sterile manufacturing in a regulated environment.

Aufgaben

• Lead and oversee non-sterile operations focusing on packaging, inspection, and Auto Injector Assembly.
• Own operational performance across safety, quality, delivery, cost, and people with accountability and measurable results.
• Strengthen capabilities through operational rigor, process robustness, and technology enablement.
• Ensure sustained cGMP compliance through quality systems, documentation, investigations, CAPA, and risk management.
• Support technology transfer, scale-up, and commercialization across packaging, device assembly, OSD, and CM programs.
• Develop high-performing teams and foster a culture of engagement and continuous improvement.

Kenntnisse

Operations leadership

Regulatory compliance

Continuous improvement

Strategic financial acumen

Travel readiness

Ausbildung

Bachelor’s degree in Engineering or related field

Tools

Automated assembly systems

Continuous manufacturing technologies

CAPA systems

Jobbeschreibung

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

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 single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

As part of the Drug Product Division (DPD), the Greenville, North Carolina site is a multi-purpose pharmaceutical development, manufacturing, and packaging campus. The operation specializes in taking both sterile injectable and oral solid dose drug products from development phase through to commercialization.

Position Summary

The Director, Non-Sterile Operations provides strategic and operational leadership for non-sterile manufacturing operations, with primary accountability for packaging, inspection, and device assembly, including Auto Injector Assembly. The role also oversees Oral Solid Dose (OSD) and Continuous Manufacturing (CM) platforms as part of the site’s non-sterile portfolio.

This position ensures the safe, compliant, and efficient execution of manufacturing and packaging activities from development through commercialization. The Director drives operational excellence and continuous improvement while partnering cross-functionally to deliver performance across safety, quality, delivery, cost, and people in alignment with evolving site priorities and growth platforms.

Key Responsibilities

• Lead and oversee non-sterile operations with primary focus on primary and secondary packaging, inspection, and Auto Injector Assembly, while maintaining operational excellence across OSD and Continuous Manufacturing platforms.
• Own operational performance across safety, quality, delivery, cost, and people, driving accountability and measurable results.
• Strengthen packaging, inspection, device assembly, OSD, and CM capabilities through operational rigor, process robustness, and appropriate technology enablement.
• Ensure sustained cGMP compliance through strong quality systems, documentation practices, investigations, CAPA, and risk management.
• Support technology transfer, scale-up, and commercialization activities across packaging, device assembly, OSD, and CM programs.
• Develop high-performing teams and foster a culture of engagement, accountability, and continuous improvement.

Qualifications

• Bachelor’s degree in Engineering, Operations Management, or related field (or equivalent experience).
• 10+ years of progressive operations leadership experience in pharmaceutical or biopharmaceutical manufacturing, including sterile manufacturing in a regulated environment.
• Demonstrated experience in a cGMP-regulated environment, including strong understanding of regulations governing sterile injectable packaging, combination products, and medical device manufacturing (e.g., FDA 21 CFR Parts 210/211, 820, EU GMP, and applicable ISO standards).
• Experience with automated assembly systems, high-speed packaging lines, continuous manufacturing technologies, and continuous improvement methodologies preferred.
• Strong leadership, financial, and strategic acumen with the ability to influence stakeholders and build high-performing teams.
• Ability to travel up to 25% including international locations.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.