Senior Toxicologist

Eurofins•Lancaster, PA

2d•Onsite

About The Position

Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to various industries, aiming to make life and our environment safer, healthier, and more sustainable. Eurofins is a global leader in food, environment, pharmaceutical, and cosmetic product testing, as well as agroscience Contract Research Organisation services. The company also holds a significant market position in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences, and clinical study support. With a network of 900 laboratories in over 50 countries and 55,000 staff, Eurofins offers over 200,000 analytical methods. As a Senior Toxicologist, you will be responsible for preparing toxicological risk assessments for medical device extractable and leachable compounds, container closure systems, and single-use systems. You will also develop read-across approaches, interpret QSAR models, conduct gap analyses, prepare biological evaluation plans and reports, and perform peer reviews of toxicological reports. Additionally, you will handle responses to regulatory deficiencies, assess client requirements, provide strategic input, and maintain professional development through memberships and participation in industry groups. The role involves leading projects, identifying best practices, and driving continuous improvement.

Requirements

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
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

Nice To Haves

> 3 years of experience in performing biological evaluations/reports and TRAs in accordance with ISO 10993-17:2023
Strong leadership, initiative, and teambuilding skills

Responsibilities

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