Senior Scientist — Regulatory Cardiac Safety​/Electrophysiology; Scientist II

Senior Scientist — Regulatory Cardiac Safety/Electrophysiology (Scientist II)

• Full-time

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 laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations.

It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years.

The Senior Scientist ensures study design; execution and reporting align with regulatory and client project specifications. The Senior Scientist provides critical client consultation throughout study life cycle and ensures lab compliance to study design. This role will support Electrophysiology projects including cardiac safety screening in a GLP-compliant electrophysiology lab and serve as a Principal Investigator for regulated studies. This role requires technical expertise, portfolio leadership, leadership competencies, and proficiency in client communication within a contract research organization.

• Develops client and stakeholder relationships through technical leadership and collaboration
• Manages client projects in all phases of study life cycle from study design to reporting
• Provides guidance and oversight for compliance and scientific integrity of the studies to ensure that studies are performed in a compliant manner
• Understands and follows all procedures and processes required for work performed under Regulatory Compliance (i.e. GxP, FDA/GLP and GCP, OECD, CLIA, etc.) and completes annual GLP training
• Directs investigations of service operations, such as deviation reports, non-conforming reports, corrective action reports, etc. Produces documentation according to established standards
• Drafts and approves operations documents to assure consistency with regulatory standards and requirements. (I.e. SOPs, batch records, training records, etc.)
• Responsible for data generation, review, analysis review and ensuring accuracy and integrity of reporting
• Provides scientific guidance that supports technical writing and final review of Validation Plans and Reports as required
• Supports client services team in generating proposals, RFPs, study plans and scope of work preparation. Assists pricing team in completing custom pricing and cost analysis
• Completes required training and supports 100% of Employee Health and Safety requirements
• Manages responsible use of confidential IT and business systems, as required
• Ensures accurate data management and reporting, with the highest integrity, and manages quality control on project data and reports
• Accountable for delivering to unit and site key performance metrics (quality, delivery on time)
• Supports site goals and demonstrates Eurofins' competencies, as defined in the job plan
• Provides training to colleagues and external end users, when required
• Performs other duties, as…