Toxicologist

Tunnell Government Services • Bethesda, MD

1d • Remote

About The Position

Tunnell Government Services, Inc. is seeking a Toxicologist Subject Matter Expert to provide technical authority in the scientific analysis of the safety and effectiveness of medical devices. The role involves authoritatively analyzing scientific data submitted to the FDA to support scientific evaluations required for medical device review. The successful candidate will assess risks to human health from chemical exposures and evaluate hazards, dose-response and exposure data, adverse responses, and mechanisms of material/tissue interactions involving extractables and leachables from polymers and metal alloys. The work draws on toxicology, immunotoxicology, and genetic toxicology.

The candidate will work independently and as part of matrixed teams involving federal and contract staff from different disciplines and backgrounds. This position is 100% telecommuting, although employees and contractors must comply with any onsite, safety, and health requirements specified by client contracts.

Requirements

• PhD or equivalent advanced degree from an accredited or pre-accredited university in Toxicology, or in Biology and Chemistry.
• At least five years of experience assessing risks to human health from chemical exposure, conducting chemical hazard identification, and selecting studies for quantitative dose-response and exposure assessments.
• Experience assessing adverse responses and relevant mechanisms of material/tissue interactions associated with extractables and leachables from polymers and metal alloys, using toxicology, immunotoxicology, and genetic toxicology approaches.
• Mastery of the principles, practices, and theories of toxicology and risk assessment.
• Knowledge of scientific principles, theories, and practices in toxicology and assessment of human health risks posed by chemicals, extractables, and leachables.
• Familiarity with applicable guidance and standards, including FDA Biocompatibility Guidance; Basics of Biocompatibility: Information Needed for Assessment by the FDA; ISO 10993-1:2018; ISO 10993-17:2002; ISO 10993-18:2020; ISO TS 21726:2019; and ICH M7.
• Ability to work remotely and independently, as well as within matrixed teams.
• Excellent written and verbal communication skills.
• Facility with Microsoft Office programs, including Word, PowerPoint, and Excel.
• Must be a U.S. citizen or full green card holder.

Nice To Haves

• Experience related to medical devices.
• Experience with in silico and computational methodologies for toxicological risk assessment.
• A strong track record of research and peer-reviewed publications in chemical hazard identification, toxicology, and risk assessment.
• Board certification or relevant certification, such as from the American Board of Toxicology or the Academy of Toxicological Sciences.

Responsibilities

• Serve as a technical authority in scientific analyses of the safety and effectiveness of medical devices.
• Provide authoritative analysis of scientific data submitted to the FDA to support medical device review evaluations.
• Conduct assessments of risks to human health from chemical exposure and perform chemical hazard identification.
• Select studies for quantitative dose-response and exposure assessments.
• Assess adverse responses and relevant mechanisms of material/tissue interactions associated with extractables and leachables from polymers and metal alloys.
• Work independently and collaboratively in matrixed teams involving federal and contract staff.

What This Job Offers

• Job Type: Full-time
• Education Level: Ph.D. or professional degree