Study Director II - Particulate Testing Lab

About the role

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. Drive Scientific Excellence. Lead Complex Studies. Make an Impact on Patient Safety. Are you a scientist who enjoys leading complex projects, partnering with customers, and translating technical data into meaningful outcomes? We are seeking an experienced Study Director II to serve as the scientific and operational leader for medical device and healthcare-related testing studies. In this role, you will oversee the technical conduct of assigned studies from initiation through final reporting, ensuring scientific quality, regulatory compliance, and exceptional customer service throughout the process. As the primary point of accountability for assigned studies, you will work closely with customers, laboratory personnel, quality teams, and cross-functional partners to deliver accurate, timely, and scientifically sound results that help bring safe and effective healthcare products to market.

Responsibilities

• Serve as the primary scientific lead and single point of control for assigned studies.
• Direct the technical execution of studies from initiation through final report issuance.
• Review, interpret, analyze, and communicate study results.
• Prepare, review, and approve technical reports and study documentation.
• Collaborate on test method development, validations, and equipment validations.
• Review and approve customer specifications and study requirements.
• Serve as a document owner for assigned standard test procedures and laboratory documentation.
• Stay current on scientific and industry developments and contribute to technical publications and knowledge-sharing initiatives.
• Serve as the primary point of contact for study-related scientific discussions.
• Build strong relationships with customers through timely communication and technical expertise.
• Collaborate with sponsors to understand testing objectives and project requirements.
• Partner with Sales and Business Development teams to support project estimates and customized testing solutions.
• Communicate study progress, findings, timelines, and recommendations.
• Resolve testing, quality, and service-related issues with professionalism and urgency.
• Manage multiple studies simultaneously while maintaining quality and customer expectations.
• Coordinate activities across laboratory departments to ensure projects remain on schedule.
• Proactively identify risks and implement solutions to keep studies moving forward.
• Ensure study milestones and deliverables are achieved within established timelines.
• Partner with internal stakeholders to support both routine and non-routine testing programs.
• Ensure all studies are conducted in accordance with applicable regulatory, quality, and laboratory requirements.
• Investigate and resolve assigned quality events and study-related issues.
• Support internal audits, customer audits, and laboratory inspections.
• Contribute to continuous improvement efforts that enhance quality, efficiency, and regulatory compliance.
• Maintain accurate and complete study documentation.
• Provide guidance and mentorship to less experienced Study Directors and laboratory staff.
• Support training and development initiatives within the laboratory.
• May supervise team members or lead special projects and initiatives.

Requirements

• The ideal candidate combines strong scientific expertise with outstanding communication and project leadership skills.
• They are comfortable serving as the technical lead on complex studies, interacting directly with customers, interpreting and communicating scientific data, and managing multiple projects in a fast-paced, regulated laboratory environment.
• Candidates with experience in medical device testing, microbiology, sterility assurance, pharmaceutical sciences, biomedical research, or related life science disciplines are highly encouraged to apply.
• Preferred areas of expertise: Medical Device Testing, Sterility Assurance, Microbiology, Biocompatibility, Biomaterials, Pharmaceutical Sciences, Biomedical Sciences, Validation & Verification, Quality Systems, GLP, GMP, and/or ISO-regulated environments.
• Required qualifications: Strong technical writing and scientific communication skills; Experience leading scientific studies, laboratory projects, or testing programs; Ability to manage customer interactions and project timelines.

Qualifications

Education & Experience: Master's degree in Life Sciences or a related scientific discipline preferred OR Bachelor's degree in Life Sciences or a related scientific discipline and at least one year of Study Director experience OR Associate degree (or equivalent) and a minimum of three years of laboratory experience as a Study Director.

Skills

• Strong scientific reasoning and analytical skills