Senior Principal Investigator/Principal Investigator at Eurofins

Lenexa, Kansas, United States -

Full Time

Start Date

Immediate

Expiry Date

30 Sep, 26

Salary

0.0

Posted On

02 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Bioanalytical Sample Analysis, Project Management, GxP Compliance, Study Design, Client Relationship Management, Resource Allocation, Regulatory Reporting, FDA Requirements, OECD Requirements, ICH Requirements, Watson LIMS, IDBS Electronic Laboratory Notebook, Microsoft Office, Lean Six Sigma, Drug Development, Bioanalysis

Industry

Medical and Diagnostic Laboratories

Description

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 50,000 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 specialized clinical diagnostics testing. In 2021, Eurofins generated total revenues of EUR € 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description Are you a scientific leader who thrives working in cutting-edge research, fosters solid client partnerships, and excels in project management? Join our amazing Eurofins Viracor BioPharma Services team as a Senior Principal Investigator (SPI)/Principal Investigator (PI) (assigned level will be dependent on experience) and play a pivotal role in bringing innovative therapies closer to patients. In this key position, you'll serve as the scientific and operational lead for bioanalytical sample analysis studies partnering with sponsors, toxicology and clinical teams, laboratory scientists, and business stakeholders to deliver high-quality, compliant, and timely results. From study design through final reporting, you'll be the trusted expert guiding projects to success while building strong client relationships and ensuring scientific excellence. Here's what you'll do: Serve as a key point of contact for new and existing customers. Manage project flow from project initiation through closeout while monitoring study for contractual adherence. Be responsible for interface with Business Development to ensure change orders are timely if needed. Create sample analysis outlines and manages amendments. Review sample analysis/validation data and reports in support of non-regulated and regulated methods. Assure the quality of the data and compliance with applicable SOPs and regulatory requirements. Develop and maintain 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. Provide guidance on analytical issues, project technical requirements, design, and logistics. Organize resource allocation/scheduling, contribute to company forecasts and revenue recognition based on project specifications and timelines. Design and improve processes and procedures to increase efficiency, productivity, and quality Travel as needed to visit Sponsor and attend scientific meetings and workshops. Arrange specimen and data handling for all services Transfer reports to customers per agreements Oversee study records, data and sample storage Coordinate transfers of hard copy project records to Quality for archiving Maintain accurate client databases, support client audits, assist with the writing of company SOPs Apply GxP (GLP/GCP) in all areas of responsibility, as appropriate Qualifications The ideal candidate: Knowledge of current United States FDA requirements and guidance on bioanalytical method development and sample analysis, familiarity with OECD and ICH requirements, and current best practices in bioanalysis. Knowledge of preclinical and clinical drug development, clinical study designs and procedures. Strong working knowledge of Microsoft Office applications, particularly Word, Excel, Outlook, and PowerPoint; Watson LIMS; required use of IDBS Electronic Laboratory Notebook as core laboratory tool (after training) for all lab activities. Bachelor's Degree in a science related field desired or equivalent work experience. 2-5 years’ experience in drug development Experience in a Contract Research Organization preferred Lean / Six Sigma experience preferred PM Certification Additional Information The position is full-time, Monday-Friday, 8 a.m.- 5 p.m., with overtime as needed. Candidates within a commutable distance of Lenexa, KS 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 USA Clinical Trial Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Responsibilities

Serve as the scientific and operational lead for bioanalytical sample analysis studies, managing projects from initiation to closeout. Coordinate between sponsors, laboratory scientists, and business stakeholders to ensure high-quality, compliant, and timely results.