Senior Toxicologist

Eurofins USA BioPharma Services•Lancaster, PA

2d•Onsite

About The Position

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

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
Strong leadership, initiative, and teambuilding skills

Nice To Haves

> 3 years of experience in performing biological evaluations/reports and TRAs in accordance with ISO 10993-17:2023

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