Senior Scientist — Regulatory Cardiac Safety/Electrophysiology (Scientist I at Eurofins

Saint Charles, Missouri, United States -

Full Time

Start Date

Immediate

Expiry Date

13 Jan, 26

Salary

0.0

Posted On

15 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Electrophysiology, Cardiac Safety, GLP Compliance, Project Management, Client Relationship Development, Technical Writing, Data Management, Scientific Integrity, Team Leadership, Drug Discovery, Regulatory Compliance, Method Validation, Interpersonal Skills, Communication Skills, Training and Mentoring, Quality Control

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 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. Job Description 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. Senior Scientist — Regulatory Cardiac Safety/Electrophysiology (Scientist II) responsibilities include, but are not limited to, the following: The Senior Scientist is a scientific leadership position, responsible for providing guidance and alignment between our customer base, the industry at large, commercial teams and service operations. This role is a hands-on laboratory-based role and will be collaborative and influential in a broad network of business functions in support of delivering high quality services to our valued customers, and driving business growth, brand recognition, and alignment with Eurofins core competencies. This position will train and mentor junior staff, responsible to take informed decision to move projects ahead, set direction, champion change and directly contribute to achieving departments goals and strategies. 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 assigned Qualifications Basic Minimum Education Qualifications: M.A. or M.S. with minimum 5 years relevant experience OR Ph.D. with minimum 3 years relevant experience Basic Minimum Qualifications: Demonstrated experience in manual patch clamp electrophysiology in a GLP-compliant laboratory is a plus. Scientific expertise in Ion Channel electrophysiology and applications to execute safety pre-clinical studies. Technical experience and knowledge in supporting compound cardiac safety profiling within drug discovery programs, from early drug discovery to IND submission life cycle. Experience developing client relationships, supporting technical correspondence, drafting and presenting scientific proposals to clients. Experience in drafting and executing equipment and method validation according to 21CFR11 compliance. Authorization to work in the United States indefinitely without restriction or sponsorship. The Ideal Candidate Possesses the Following: Demonstrates a positive attitude, capacity for team environment, and exhibits a genuine interest in drug discovery in support of advancing human health. Excellent interpersonal, verbal and written skills, including ability to prepare detailed scientific reports and group presentations. Demonstrates a working understanding of international regulatory requirements and aptitude to stay relevant on topical scientific publications. Ability to support project management, plan and coordinate multiple projects simultaneously, with appropriate allocation of available resources. Demonstrated experience in working effectively with lab operations, business development, marketing, and outsourcing stakeholders. Experience with leading and influencing cross-functional teams effectively Additional Information Position is full-time, with overtime as needed. Candidates currently living within a commutable distance of St. Charles, MO 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 Discovery Services is a Disabled and Veteran Equal Employment Opportunity employer.

Responsibilities

The Senior Scientist is responsible for ensuring study design, execution, and reporting align with regulatory and client project specifications. This role includes managing client projects throughout the study life cycle and providing scientific guidance to ensure compliance and integrity of studies.