About this 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.
Ideal Candidate
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.
What You'll Do
Scientific Leadership
- 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.
Customer Partnership
- 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.
Project & Study Management
- 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.
Quality & Compliance
- 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.
Leadership & Mentoring
- 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.
What Makes You Successful
- Strong scientific reasoning and analytical skills
- Exceptional technical writing and documentation abilities
- Excellent verbal communication and presentation skills
- Ability to explain complex scientific concepts to both technical and non-technical audiences
- Strong customer relationship management skills
- Effective project management and organizational abilities
- Ability to prioritize and manage multiple projects simultaneously
- Strong problem-solving and decision-making skills
- Experience working in regulated laboratory environments
- Ability to collaborate across departments and build strong working relationships
- Conflict resolution and stakeholder management skills
Preferred Areas of Expertise
Experience in one or more of the following areas is highly desirable:
- Medical Device Testing
- Sterility Assurance
- Microbiology
- Biocompatibility
- Biomaterials
- Pharmaceutical Sciences
- Biomedical Sciences
- Validation & Verification
- Quality Systems
- GLP, GMP, and/or ISO-regulated environments
Qualifications
Required
- Strong technical writing and scientific communication skills
- Experience leading scientific studies, laboratory projects, or testing programs
- Ability to manage customer interactions and project timelines
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
Why Join Us?
Join a team that plays a critical role in advancing healthcare and medical device innovation. As a Study Director II, you'll have the opportunity to work directly with industry-leading customers, lead impactful scientific studies, and contribute to products that improve patient safety worldwide. You'll collaborate with talented scientific professionals, expand your technical expertise, and grow your career in a dynamic and highly respected laboratory environment.
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.