[Remote] Sr Biopharma Scientist

Note: The job is a remote job and is open to candidates in USA. Myriad Genetics is a leading company in the biopharmaceutical sector, and they are seeking a Senior Biopharma Scientist to support verification and validation activities for molecular diagnostic products. The role involves developing and executing strategic assay analytical validation plans and collaborating with various teams and stakeholders to meet regulatory requirements. 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. Skills • 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) Company Overview • Myriad Genetics discovers, develops, and commercializing novel therapies for the treatment of cancer. It was founded in 1991, and is headquartered in Salt Lake City, Utah, USA, with a workforce of 1001-5000 employees. Its website is Apply tot his job