Company 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.
Oversees and monitors the development and implementation of clinical biomarker and bioanalytical plans for clinical programs across the portfolio, including biomarkers, PK, and immunogenicity strategies, to enable forward and reverse translation and patient characterization activities.
Provides strategic oversight for vendor selection, assay development, transfer and validation of biomarker, PK, and immunogenicity assays for clinical programs.
Accountable for timely delivery of quality assay results and working with project teams to ensure program needs are met.
Collaboratively interact with scientists from other functional areas in QTS, as well as from other divisions, affiliates, and alliance partners, as needed.
BS or MS in Biology, Immunology, or related discipline
Minimum 6 years of drug development experience with clinical biomarkers and bioanalytical methods
Incumbent must demonstrate a sustained record of scientific productivity in the field of clinical biomarkers and bioanalytical methods.
Pharmaceutical drug development experience with a strong focus on clinical biomarker and bioanalytical methods including pharmacokinetics and immunogenicity.
Must have scientific and technical expertise as evidenced by publications, patents, awards/honors and credibility at professional societies. Alternatively, must have evidence of successful utilization of scientific and technical principles in negotiation of project goals with internal management and/or regulatory agencies.
Thorough understanding of drug development and global regulatory requirements.
Excellent oral and written communication skills, including writing, reviewing, and editing scientific documents.
Ability to effectively influence colleagues and multi-disciplinary project teams.
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 Cambridge, MA 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.