Senior Scientist - Regulatory Cardiac Safety/Electrophysiology responsibilities include, but are not limited to, the following :
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 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
The ideal candidate would possess :
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
Basic Minimum Qualifications :
M.A. or M.S. with 5 years relevant experience
Ph.D. with 3 years relevant experience
Combination of Education and Relevant Experience
Demonstrated experience in manual patch clamp electrophysiology in a GLP-compliant laboratory.
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
Position is full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed. Candidates currently living within a commutable distance of Cambridge, MA are encouraged to apply.
As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options.
To learn more about Eurofins, please explore our website www.eurofinsus.com .
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
