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 – Extractables & Leachables is a trusted advisor and consultative expert for clients and serves as the initial customer contact for extractable and leachable studies and projects. This position requires a high degree of consultation and the highest level of customer service and technical expertise. The Consulting Study Director assists Sales with quote generation, sponsor communication, develops test protocols, and can facilitate testing of extractables and leachables study in the lab. 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.). Specifically chemical characterization testing per ISO10993-18. Significant experience required with medical device or pharma extractable and leachable testing (medical device E&L is preferred). Collaboratively develop extractable and leachable test protocols and testing strategies to meet client expectations and regulatory needs. 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 and email contact. Build strong relationships with clients, Sales, Service Center, and the Lab team. Regulatory Compliance Follow applicable regulatory requirements (GMP, GLP, ISO, etc.) including ISO10993-18. Respond to FDA feedback of Nelson Labs testing strategies and studies. Stay current on regulatory trends. Follow internal 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 Chemistry or related field preferred At least 5 years Extractables and Leachables lab experience. 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. Come Make a Difference with Us. Sotera Health is driven by its mission, Safeguarding Global Health®. Along with our three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs® – we are a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. Not finding the right fit? Let us know you're interested in a future opportunity by clicking Get Started below or create an account by clicking 'Sign In' at the top of the page to set up email alerts as new job postings become available that meet your interest!