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:ConsultingActive participation on AAMI and/or ISO working groupsDrive scientific direction for the Technical Consulting team in toxicologyServe as a mentorProvide team trainingPresent on biocompatibility at trade shows, seminars, and technical gatheringsProvide onsite or virtual training to clientsJoin calls as expert to support initial client discussionsWork cross-functionally with other departments on projects where collaboration is neededCommunicate with the client to obtain additional information for projects or related testingPerform literature research on materials and compoundsBuild and implement process improvementsKnow and follow the Nelson service standardReview and write assessments and other related documents as needed (i.e. Opinion Memos for patient safety)Regulatory ComplianceKnow 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 mustDoctorate in Toxicology (or related field), postdoctoral fellowship in a toxicological related field highly preferredAmerican Board of Toxicology Certification highly preferred7+ years related work experienceStrong background in Chemistry as well as ToxicologyCompetencies of this positionDirecting thought process through team meetingsPublishing articlesRecognized in industry as a leader (invitations to speak)Good project management skillsOwning projects with customersTaking on STAT projectsExcellent communication skillsLeading phone callsAct as SME on global regulatory calls/projectsSupporting 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 expertiseWrite regulatory responses with guidanceAttention to detailAble to handle simple to moderately difficult assignmentsTime management – must be able to respond to voicemails, emails, and other communications in a timely mannerAble to multi-task and be self-motivatedMentoring and training junior team membersPresenting in industry (outside of Nelson Seminars)Actively participating in ISO or AAMI WGsKnowledge 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 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.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.

Principal Consultant - Toxicology

Emma

Responsibilities

Skills wanted:

Language(s) required:

Angela Howe

Kim Mirabelli

Malick Sangare

Angela Howe

Kim Mirabelli

Malick Sangare

About Soterahealth:

soterahealth.com/

Admin access needed