Consulting Study Director – Extractables & Leachables

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 9 of the top 10 pharmaceutical companies. Job Summary The Consulting Study Director is a trusted advisor and consultative expert for clients and serves as the initial customer contact for validation studies, large projects, and other testing requiring a high degree of consultation. The position requires the highest level of customer service and broad technical expertise. The Consulting Study Director assists Sales with quote generation, develops test protocols, ensures testing setup is complete, and facilitates a smooth transition of projects to Production Study Directors. This enables production teams to focus on testing while delivering an exceptional client experience. The primary responsibility of this role is to help clients plan and organize projects through specialized expertise, high availability, and a high-touch customer service approach. Essential Job Functions Study Consulting Demonstrate deep understanding of industry regulations, standards, and guidelines (GMP, GLP, FDA, AAMI, ISO, ASTM, USP, etc.). Collaboratively develop test protocols and testing strategies to meet client expectations. Partner with Production Study Directors to ensure seamless project handoffs. Assist clients and production teams with unexpected or unique testing challenges. Coordinate technical consulting activities including summary protocols, written justifications, sample plan justifications, risk assessments, and special projects. Customer Focus Provide exceptional customer service. Maintain extensive client phone contact. Build strong relationships with clients, Sales, Service Center, and Production Study Directors. Regulatory Compliance Follow applicable regulatory requirements (GMP, GLP, ISO, etc.). Stay current on regulatory trends. Follow company policies and procedures. Professional Development Complete required training on time. Stay current on scientific literature, test methods, and best practices. Perform other duties as assigned. Job Requirements Excellent internal and external customer service skills. Strong technical knowledge and demonstrated technical ability. Strong verbal and written communication skills. Ability to work effectively with cross-functional teams. Project management skills. Facilitation of client and team meetings. Ability to multitask and work independently. Strong time management and responsiveness to communications. Proficiency in Microsoft Office. Regular and reliable attendance. Education & Experience Bachelor's degree in Microbiology, Biological Sciences, Chemistry, or related field preferred Atleast five years of NLI laboratory experience. Physical Requirements Must be able to stand/walk approximately 30% of the workday and sit approximately 70% of the workday, including computer work. Must occasionally lift up to 30 pounds. 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.