Senior Toxicologist

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

Qualifications :

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

Additional Information :

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.

Remote Work :

No

Employment Type :

Full-time