Director Non-Sterile Operations

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds 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 sites 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

• Bachelors 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.