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Principal Toxicologist - Salt Lake City, UT

Quick Facts
Company Name:Nelson Labs
Location:Salt Lake City, UT
Employment Type:Full Time
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At Nelson Laboratories, a Sotera Health Company, our employees are part of an industry-leading, global provider of laboratory testing and consulting services; dedicated to the mission of helping the best companies in the world improve the quality of life by providing the highest standard in laboratory testing. Our employees receive competitive pay, growth and learning opportunities, insurance benefits, tuition reimbursement, paid holidays and PTO, and the opportunity to attend many company-sponsored employee and family events.

Because Every Employee Matters, we offer comprehensive training programs, mentorship, innovative lab practices, and a culture of employee collaboration.

Job summary:

ThePRincipal Toxicologist will assist in toxicology assessments, biological safety testing, preclinical translational research and product development for medical devices, drug delivery and biologics. Liaison between chemists, material engineers, GLP test facilities, product development and product life cycle management teams.

Responsible for initiating, planning and execution of toxicology studies, assessments, and biological safety testing. Apply advanced technical expertise in the area of medical device, drug delivery and biologic toxicology research with knowledge of related disciplines such as material and regulatory science. Support evaluation of device and drug-device therapy opportunities. Conduct toxicological assessments on drug and device elements. Develops protocols, reports, and interpretation of data outcome from bioanalytical and chemical characterization to determine if safety is sufficiently supported and to provide direction and guidance on device characterization for safety assessment. Participate in the development and implementation of biological safety test strategies.

Essential job functions:

  • Works with project teams to identify and define safety risks, develop project plans, perform data-based decision making, and authorize regulatory submissions with clients.
  • Successfully transitions project and toxicological risk assessments between laboratory studies, non-clinical evaluation, and clinical experience.
  • Inputs on design phases and ensures the timely execution of preclinical safety assessments (including safety pharmacology) for products in development including pharmaceuticals, biologics, consumer products and/or medical devices.
  • Ability to search the scientific literature, extract relevant information, order, evaluate, and present information in the form of a unbiased opinion of its quality and quantity in order to aid the assessment of the safety of products.
  • Ensures that development plans and studies meet global regulatory requirements.
  • Exhibits superior interpersonal skills by serving as a core team member in cross-functional meetings to discuss project issues, clinical designs, and advancement of projects to next phase of development
  • Must be recognized as an internal and external expert in the area of preclinical safety whose scientific opinion is solicited to provide direction.
  • Exhibits superior knowledge of global testing guidelines by providing direction to Study Director/Study Monitor to ensure studies in support of preclinical safety are conducted according to GLP, ISO, OECD, ICH regulations designed appropriately to support the clinical plan, and can withstand regulatory agency review.
  • Must have a keen sense of urgency and superior communication skills (both oral and written).
  • Deliver technical presentations of services to external and internal clients.

Regulatory Compliance

  • Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.)
  • Know and follow company policies and procedures

Professional Development

  • Complete required training on time

Perform other duties as assigned

Physical requirements:

This position will Include long periods of time spent sitting and looking at a computer screen.

Education and experience requirements:

  • PhD in Molecular Biology, Neuroscience or in Toxicology
  • American Board of Toxicology, Board Certified Toxicologist with current registration
  • Experience with Analytical Chemistry preferred
  • Experience in drug or device development
  • Experience in toxicology and efficacy studies preferred.
  • Solid knowledge of CMO/CRO, medical device, pharmaceutical, and/or biotech industries is required.
  • Knowledge and expertise in toxicology standards, animal models and related research tools.
  • Minimum of 5 to 7 years industry toxicology experience in medical device/drug applications.
  • Excellent communication skills with experience working with senior/executive level teams.

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