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Eurofins DiscoverX · 1 day ago

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

St Charles, MO

Full-time

Onsite

Mid, Senior Level

3+ years exp

Eurofins Scientific is an international life sciences company providing analytical testing services across multiple industries. The Senior Scientist will ensure study design, execution, and reporting align with regulatory and client specifications, while supporting Electrophysiology projects and serving as a Principal Investigator for regulated studies.

BiotechnologyDeveloper PlatformManufacturing

No H1B

Responsibilities

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

Qualification

Manual patch clamp electrophysiologyIon Channel electrophysiologyCardiac safety profiling21CFR11 complianceClient relationship developmentTechnical writingProject managementInterpersonal skillsTeam collaboration

Required

M.A. or M.S. with minimum 5 years relevant experience

Ph.D. with minimum 3 years relevant experience

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

Benefits

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

Company

Eurofins DiscoverX

Eurofins DiscoverX, the products company of Eurofins Discovery, is committed to enabling and accelerating multi-modality drug discovery and development from discovery to QC lot release.

Founded in 2000

Fremont, Missouri, USA

51-200 employees