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.
The Principle Investigator (PI) is responsible for supporting scientifically effective and timely definition, set-up and completion of bioanalytical sample analysis studies, including authoring sample analysis plans and reviewing study reports. The Principle Investigator interfaces with external client and their toxicological or clinical partners to scope and define projects; and partners with Method Development and Validation Scientists and Laboratory Scientists to verify the scientific integrity of the data and confirm that procedures comply with internal and/or sponsor Standard Operating Procedures (SOPs) and regulatory requirements. The Principle Investigator serves as the primary Sponsor contact and manages Sponsor relationships as assigned, conducts work assignments in alignment with Sponsor specifications and timelines. Position is in St. Charles, MO.
Serves as a key point of contact for new and existing customers.
Manages project flow from project initiation through closeout while monitoring study for contractual adherence.
Responsible for interface with Business Development to ensure change orders are timely if needed.
Creates Method Validation Plans and manages amendments
Creates sample analysis outlines and manages amendments.
Reviews sample analysis/validation data and reports in support of non-regulated and regulated methods.
Assures the quality of the data and compliance with applicable SOPs and regulatory requirements.
Develops and maintains good working relationships with Sponsors, interfacing with Business Development, and Scientists to communicate and meet Sponsor needs and timelines, while providing technical information and resolving problems.
Provides guidance on analytical issues, project technical requirements, design and logistics,.
Organizes resource allocation/scheduling, contributes to company forecasts and revenue recognition based on project specifications and timelines.
Designs and improves processes and procedures to increase efficiency, productivity, and quality
Travel as needed to visit Sponsor and attend scientific meetings and workshops.
Arranges specimen and data handling for all services
Transfers reports to customers per agreements
Oversees study records, data and sample storage
Coordinates transfers of hard copy project records to Quality for archiving
Maintains accurate client databases
Supports client audits
Assists with the writing of company SOPs
Applies GxP in all areas of responsibility, as appropriate
Works effectively as a member of a team, under minimum direction to achieve client and business deadlines.
Attends internal and external training courses.
Demonstrates and promotes the company vision
Regular attendance and punctuality
Conducts all activities in a safe and efficient manner
Adjusts work hours as needed to meet client deadlines
Adheres to site employee health and safety (EHS) requirements
Performs other duties as assigned
The Ideal Candidate would possess:
Knowledge of current United States FDA requirements and guidance on bioanalytical method development and sample analysis, familiarity with OEDC and ICH requirements, and current best practices in bioanalysis.
Knowledge of preclinical and clinical drug development, clinical study designs and procedures.
Experience in an FDA or ISO regulated industry within cGMP or GLP environment
Experience in a Contract Research Organization
Basic Minimum Qualifications:
Bachelor's Degree in a science related field desired or equivalent work experience.
More than 2 years' lab, program management and data review experience
Authorization to work in the United States indefinitely without restriction or sponsorship
Position is full-time, Monday
4:30pm. Candidates currently living within a commutable distance of St. Charles, MO are encouraged to apply. Relocation reimbursement available for the right candidate.
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.