Toxicologist

Tunnell Government Services, Inc.; Bethesda (MD); Remote; USD 120,000 - 180,000; Full time

Job summary

Tunnell Government Services, Inc. seeks a Toxicologist Subject Matter Expert to support FDA risk assessments for medical devices. The role provides technical authority, analyzes safety data, and contributes to scientific evaluations required for FDA reviews.

Ideal candidates hold a PhD in Toxicology or Biology and Chemistry with at least five years of relevant experience, familiarity with ISO 10993 standards, and the ability to work effectively in virtual, matrixed teams.

Qualifications

• PhD in Toxicology, or Biology and Chemistry.
• At least five years of experience in toxicology risk assessment.
• Experience with medical devices is highly desirable.
• Knowledge of toxicology principles and risk assessment.
• Familiar with in silico toxicology and computational risk methods is beneficial.
• Familiar with ISO 10993-1/17/18 and related standards.
• Board certification or related certifications are highly preferred.
• Ability to work independently and in matrixed teams.
• US Citizenship or Full Green Card holder.
• 100% telecommuting remote work.

Responsibilities

• Serve as technical authority in scientific analysis of the safety and effectiveness of medical devices for FDA review.
• Provide authoritative analyses of scientific data submitted to the FDA for medical device evaluations.

Skills

Excellent communication skills

MS Office proficiency

Remote work capability

Education

PhD in Toxicology or Biology and Chemistry

Tools

MS Office

Job description

Tunnell Government Services, Inc., is comprised of the industry’s leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions.

Toxicologist Subject Matter Expert for FDA

Educational Requirements

Applicants should possess a PhD in Toxicology, or Biology and Chemistry with the ability to demonstrate mastery of principles, practices, and theories in the field of toxicology and risk assessment. This candidate must serve as a technical authority in the scientific analysis of the safety and effectiveness of medical devices, and provide an authoritative analysis of scientific data submitted to the Agency to support scientific evaluations required for medical device review by FDA.

Qualifications

• A PhD, or equivalent advanced degree, from an accredited or pre-accredited university in Toxicology, or Biology and Chemistry.
• A minimum of five years of experience conducting assessments of risks to human health from exposure to chemicals, chemical hazard identification, and selection of studies for quantitative dose-response and exposure assessments, including assessment of adverse responses and relevant mechanism(s) of material/tissue interactions associated with extractables and leachables from polymers and metal alloys using approaches within the disciplines of toxicology, immunotoxicology, and genetic toxicology.
• Experience related to medical devices is highly desirable.
• Knowledge of the scientific principles, theories and practices associated with the discipline of toxicology and the assessment of risks to human health posed by chemicals, extractables, and leachables.
• Experience with in silico and computational methodologies for toxicological risk assessment would be beneficial, and evidence of a strong track record of research and peer-reviewed publications in chemical hazard identification, toxicology, and risk assessment could also be beneficial.
• Familiar with the applicable guidances and standards, including, but not limited to the following:
  • FDA Biocompatibility Guidance
  • Basics of Biocompatibility: Information Needed for Assessment by the FDA
  • Standards:
    • ISO 10993-1:2018, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
    • ISO 10993-17:2002, Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
    • ISO 10993-18:2020, Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
    • ISO TS 21726:2019, Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
    • ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk (2017; R2018)

Additional Information

• Board certification or related, relevant certifications are highly preferred, e.g., American Board of Toxicology, Academy of Toxicological Sciences, etc.
• The successful candidate must be able to function independently and as part of matrixed teams involving federal and other contract staff of various disciplines and backgrounds.
• Must be able to successfully work remotely; position is 100% telecommuting.
• Must possess excellent communication skills (written, verbal) and facility with MS Office suite programs (word, PowerPoint, excel, etc.)

Must be a US Citizen or Full Green Card holder.

Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.