Director Non-Sterile Operations

Thermo Fisher Scientific

Greenville, NC

JOB DETAILS
SKILLS
Automated Assembly Equipment, Automotive Assembly, Cancer, Code of Federal Regulations, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Documentation, Drug Development, Drug Manufacturing, Drug Products, FDA (Food and Drug Administration), Financial Strategy, Food Safety, GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Leadership, Maintain Compliance, Manufacturing, Manufacturing Operations, Medical Equipment, Medical Products, Operational Strategy, Operations Management, Operations Processes, Oral Administration Drugs, Regulations, Risk Management, Safety Standards, Safety/Work Safety, Technical Support, Willing to Travel
LOCATION
Greenville, NC
POSTED
Today

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.

About the Company

T

Thermo Fisher Scientific

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $11 billion, we have approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.

All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.

If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.

Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer.

COMPANY SIZE
10,000 employees or more
INDUSTRY
All
WEBSITE
https://corporate.thermofisher.com/en/home.html