Study Director - Sterilization

Position Summary

The Study Director provides scientific and operational leadership for assigned studies, serving as the single point of accountability from initiation through final report. This role ensures technical excellence, regulatory compliance, data integrity, and timely delivery of high‑quality, defensible results to sponsors.

• Client & Cross‑Functional Collaboration/Customer Service
• Serve as the primary scientific contact for sponsors, providing technical guidance and study updates.
• Lead the technical execution of assigned studies, ensuring accuracy, traceability, and integrity of all data.
• Review, interpret, and analyze results; ensure conclusions are scientifically sound and supported by raw data.
• Prepare and approve final reports as the authorized signatory.
• Ensure accuracy of calculations, statistical analyses, and documentation.
• Partner in the development and refinement of test methods, validation protocols, and Standard Test Procedures (STPs).
• Support quality investigations and continuous improvement initiatives.
• Ensure studies comply with applicable regulatory standards (GMP, GLP, ISO, etc.).
• Confirm approved procedures are followed and deviations are properly documented and addressed.
• Collaborate with Sales on study design and quoting.
• Work closely with laboratory teams to align on scope, expectations, and deliverables.

• Strong customer service skills/ability to speak with sponsors clearly and confidently
• Strong knowledge of laboratory testing methodologies, instrumentation, and data analysis.
• Excellent critical thinking, troubleshooting, and decision‑making skills.
• High attention to detail and strong organizational abilities.
• Effective written and verbal communication skills.
• Proficiency in Microsoft Office and laboratory information systems.
• Commitment to quality, integrity, and continuous improvement.

• This role operates in a professional laboratory environment and requires the use of standard lab and office equipment. Exposure to biological and chemical materials may occur in accordance with established safety protocols.
• Ability to work in laboratory and office settings.
• Ability to wear required personal protective equipment (PPE).
• Ability to lift up to 45 lbs.

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company's unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provider of mission‑critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.

Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 8 of the top 10 global pharmaceutical companies.

Sotera Health goes to market through its three best‑in‑class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co‑60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.

Learn more about Sotera Health at