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Study Director: Medical Device

Company: AC Project
Location: Lancaster
Posted on: September 13, 2020

Job Description:

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, etc.

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 control strategies.

Author Toxicological and Biological risk assessments for regulatory compliance.

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 holders.

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 labs.

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 teams.

Strong written and verbal communication skills of technical subject matter.

Understanding of analytical chemistry methods. Knowledge of animal testing is a plus.

Laboratory experience in analytical chemistry in vitro and in vivo.

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.

Other jobs at Eurofins USA BioPharma Services

Keywords: AC Project, Lancaster , Study Director: Medical Device, Other , Lancaster, Pennsylvania

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