As a Senior Toxicologist your responsibilities will include, but are not limited to, the following:

Independently prepare toxicological risk assessments (TRAs) on medical device extractable and leachable compounds in accordance with ISO 10993-17:2023
Independently prepare toxicological risk assessments on container closure and single-use system extractable and leachable compounds
Demonstrate expertise in developing scientifically justified read-across approaches and interpreting QSAR model outputs
Conduct gap analyses and independent data reviews
Develop biological evaluation plans (BEPs) and reports (BERs)
Perform peer review of toxicological reports to ensure scientific accuracy, quality, and regulatory compliance
Independently prepare and submit responses to regulatory deficiencies, maintaining high scientific and regulatory standards
Assess and interpret client requirements to provide strategic input on new projects
Pursue and maintain relevant professional memberships to support ongoing professional development
Display leadership and initiative (e.g., process improvements, development of meeting abstracts/presentations)
Remain abreast of advances in the field (e.g., participation in AAMI working groups)
Proactively identify and implement best practices to drive continuous improvement
Lead and coordinate projects of moderate scope, demonstrating autonomy and accountability

Your Basic Minimum Qualifications:

PhD in Toxicology or related field with 2-5 years of relevant experience
MS in scientific discipline with a minimum of 7 years of experience in toxicology or related field
BS in scientific discipline with minimum of 10 years of experience in toxicology or related field
Demonstrated proficiency in ISO 10993 requirements, with comprehensive knowledge of applicable industry and regulatory standards
Strong expertise in toxicology, including systemic, carcinogenic, and reproductive/developmental toxicity, with comprehensive knowledge of risk assessment principles
Authorization to work in the United States indefinitely without restriction or sponsorship

As the ideal candidate you would possess:

> 3 years of experience in performing biological evaluations/reports and TRAs in accordance with ISO 10993-17:2023
Strong computer, scientific, and organizational skills
Excellent communication (oral and written) and attention to detail
Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
Strong leadership, initiative, and teambuilding skills

What we offer:

Excellent full time benefits including comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.