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 believes it is a global leader in food,
environmental, pharmaceutical and cosmetics products testing and in
agroscience CRO services. It is also one of the global independent
market leaders in certain testing and laboratory services for
genomics, discovery pharmacology, forensics, CDMO, advanced
material sciences and in the support of clinical studies.
In over just 30 years, Eurofins has grown from one laboratory in
Nantes, France to over 47,000 staff across a network of more than
900 independent companies in over 50 countries and operating more
than 800 laboratories. 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, as well as providing innovative clinical
diagnostic testing services, as one of the leading global emerging
players in specialised clinical diagnostics testing.
In 2019, Eurofins generated total revenues of EUR € 4.56
billion, and has been among the best performing stocks in Europe
over the past 20 years.
Job Description As a Study Director, your responsibilities
will include, but are not limited to, the following :
Conduct toxicological and biocompatibility assessment of client
products with regard to product design, design changes,
manufacturing process and post-production life-cycle activities,
Act as the subject matter expert (SME) for the design and
execution of toxicological and biocompatibility testing. Advise on
data requirements and biocompatibility and toxicological risk
Author Toxicological and Biological risk assessments for
Provide advice on testing strategy and test design.
Work with Client/Regulatory Affairs to answer feedback from
regulatory agencies on issue relating to biological safety.
Prepare and present technical presentations to key stake
Maintain and evolve quality system documentation and procedures
relevant to toxicological and biological risk assessment.
Train staff on new procedures/documents.
Maintain strong relationship with internal and external test
Remain current and apply the understanding of ISO 10993, ISO
14971 and regulatory agency guidance documents (e.g. FDA, PMDA
etc.) and pertinent quality system requirements.
Qualifications As the ideal candidate you would possess
Ability to manage multiple projects in cross functional
Strong written and verbal communication skills of technical
Understanding of analytical chemistry methods. Knowledge of
animal testing is a plus.
Laboratory experience in analytical chemistry in vitro and in
Your Basic Minimum Qualifications :
Seniority – mid/associate level; 3-5 yrs experience
PhD degree in Toxicology or relevant experience combined with
internationally recognized certification in toxicology.
Experience from medical device or pharmaceutical industry.
Knowledge of ISO 10993 and interpretation in domestic and
international regulatory settings.
Must have good knowledge to use available toxicological software
or database to analyze and interpret test results.
Authorization to work in the United States indefinitely without
restriction or sponsorship
Additional Information Position is full-time, Monday - Friday
8:00am - 5:00pm. Candidates currently living within a commutable
distance of Lancaster, PA are encouraged to apply.
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 is a M/F, Disabled, and Veteran Equal Employment
Opportunity and Affirmative Action employer.
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