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Myriad Genetics · 3 days ago

Sr. Biopharma Validation Scientist

United States

Full-time

Remote

Mid, Senior Level

4+ years exp

Myriad Genetics is a company focused on molecular diagnostics and regulatory compliance. The Sr. Biopharma Validation Scientist is responsible for supporting verification and validation activities for molecular diagnostic products, ensuring compliance with domestic and international regulatory requirements, and leading cross-functional collaborations to achieve business objectives.

BiotechnologyPharmaceuticalPrecision Medicine

No H1B

U.S. Citizen Only

Responsibilities

Develop comprehensive and strategic assay analytical validation plans based on alignment with regulatory agency expectations

Design, plan, write, and lead validation/verification studies focusing on companion diagnostics that must adhere to domestic (e.g., US FDA, CLIA, CAP, NYSDOH) and international (e.g., Japan PMDA, Europe IVDD/IVDR) regulatory requirements. Compile and/or direct the compilation of validation/verification documents (e.g., protocols, reports, supporting data, and technical files), ensuring on-time submissions to regulatory agencies. Respond to queries from regulatory agencies

Identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans

Ensure Quality System Regulations (QSR), CLIA, CAP, NYSDOH, and international regulatory compliance (e.g., ISO 13485) for molecular diagnostic testing. Conduct projects according to design control and industry good practices (GxP). Participate in device and process improvements as needed. Participate in audits as needed

Cross-functional collaboration and coordination with program/project managers, applicable teams, and stakeholders to achieve business objectives, deliverables, and timelines

Support applicable requests for business/project proposals, e.g., new CDx intended uses with pharmaceutical partners

Provide training for new and existing team members and throughout the organization as needed. Supervise team members as needed

Perform other related duties as needed

Qualification

Regulatory complianceAnalytical validationMolecular diagnosticsQuality System RegulationsCross-functional collaborationCommunicationAttention to detailIndependent work

Required

Ph.D. or related degree in life sciences with a minimum of 4 years of clinical molecular diagnostics experience; OR

M.Sc. in life sciences with a minimum of 5 years of clinical molecular diagnostics experience; OR

B.Sc. in life sciences with a minimum of 7 years of clinical molecular diagnostics experience

Experience and knowledge of regulatory agency analytical validation expectations for IDE, clinical performance studies, sPMA, and PMA submissions

Work experience in domestic and international regulated molecular diagnostic tests, especially in analytical and/or clinical validations. For example, US FDA approved In Vitro Diagnostic devices, QSR, CLIA, CAP, NYSDOH, Japan PMDA, and Europe

Strong scientific expertise and knowledge base in molecular diagnostic testing

Excellent written and oral communication skills

Proven ability for productive cross-functional teamwork to achieve company/project goals and timelines

Ability to lead and work independently. Attention to detail and accuracy

Applicant must be a (i) U.S. citizen or national, (ii) U.S. lawful, permanent resident (aka green card holder)