Principal Consultant - Toxicology

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 Principal Consultant - Toxicology is a senior team member within the Technical Consulting Team. The Principal Consultant is responsible for the scientific direction of the program on the Team for Toxicology; as a member of the Technical Consulting Team, they will guide the direction of the written assessments within their discipline. This will include staying updated on the latest standards, industry and regulatory direction, and science of their discipline. The Principal Consultant will also present on topic of expertise at seminars, trade shows, and technical gatherings. This individual will also participate in generating written information related to their specific science of discipline (e.g., risk assessments, technical protocols, etc.) the Principal Consultant will also mentor colleagues and provide valuable training to support new hires and growth of experts. Essential Duties: Consulting

• Active participation on AAMI and/or ISO working groups
• Drive scientific direction for the Technical Consulting team in toxicology
• Serve as a mentor
• Provide team training
• Present on biocompatibility at trade shows, seminars, and technical gatherings
• Provide onsite or virtual training to clients
• Join calls as expert to support initial client discussions
• Work cross-functionally with other departments on projects where collaboration is needed
• Communicate with the client to obtain additional information for projects or related testing
• Perform literature research on materials and compounds
• Build and implement process improvements
• Know and follow the Nelson service standard
• Review and write assessments and other related documents as needed (i.e. Opinion Memos for patient safety)

Regulatory Compliance

• Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.).
• Know and follow company policies and procedures.
• Complete required training on time.

Education and experience requirements:

• Master’s degree in Toxicology (or related field) is a must
• Doctorate in Toxicology (or related field), postdoctoral fellowship in a toxicological related field highly preferred
• American Board of Toxicology Certification highly preferred
• 7+ years related work experience
• Strong background in Chemistry as well as Toxicology

Competencies of this position

• Directing thought process through team meetings
• Publishing articles
• Recognized in industry as a leader (invitations to speak)
• Good project management skills
• Owning projects with customers
• Taking on STAT projects
• Excellent communication skills
• Leading phone calls
• Act as SME on global regulatory calls/projects
• Supporting all regulatory response projects (either by leading or supporting)
• Able to handle ALL devices and projects (including combination, 18562, nanoparticles, etc.)
• Excellent technical writing skills and expertise
• Write regulatory responses with guidance
• Attention to detail
• Able to handle simple to moderately difficult assignments
• Time management – must be able to respond to voicemails, emails, and other

communications in a timely manner

• Able to multi-task and be self-motivated
• Mentoring and training junior team members
• Presenting in industry (outside of Nelson Seminars)
• Actively participating in ISO or AAMI WGs
• Knowledge Microsoft Office applications (Word, Excel, PowerPoint, Outlook, etc.)

Work Environment: This job operates in a professional office and laboratory environment. This role routinely uses standard office equipment such as computers, keyboards, computer mouse, telephones, photocopiers, projectors and file cabinets. Occasional travel during the business day. Some out-of-the area and overnight travel may be expected. May be required to attend domestic and international trade shows, seminars and conferences. Physical requirements: Must be able to stand/walk for 10% of the day and 90% of the day sitting at a desk or on the computer. Must be able to attend trade shows, seminars, and conferences. Must be able to occasionally lift a maximum of 45lbs. May require modified work hours to cover travel and work in other time zones. 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.