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

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) Duties 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
Train/mentor junior staff. May have direct report responsibilities
​​​​​​Basic Minimum Education & Experience Qualifications:
M.A. or M.S. with 5 years relevant experience
Ph.D. with 3 years relevant experience
Basic Minimum Work Requirements:
Other Factors: Successful completion and compliance of the company's safety program required
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.
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

Skills
GCP, Project Management, Technical Writing, Business Development, Quality Control, Regulatory Compliance, Documentation

Employment type
Full-time

Work arrangement
No