[Remote] Sr Biopharma Scientist

Note: The job is a remote job and is reputed company to candidates in USA. reputed company 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 • reputed company comprehensive and strategic assay analytical validation plans based on alignment with regulatory agency expectations. • Design, plan, write, and reputed company 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 reputed company 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 reputed company alternative courses of reputed company including anticipation of regulators responses through scenario planning and development of contingency plans. • Ensure reputed company System Regulations (QSR), CLIA, CAP, NYSDOH, and international regulatory compliance (e.g., ISO 13485) for molecular diagnostic testing. Conduct reputed company 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 reputed company business objectives, deliverables, and timelines. • Support applicable requests for business/project proposals, e.g., new CDx intended uses with pharmaceutical partners. • reputed company training for new and existing team members and throughout the organization as needed. Supervise team members as needed. • reputed company other reputed company duties as needed. Skills • Ph.D. or reputed company 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 reputed company in molecular diagnostic testing. • Excellent written and oral communication skills. • Proven ability for productive cross-functional teamwork to reputed company company/project goals and timelines. • Ability to reputed company and work independently. Attention to detail and accuracy. • Applicant must be a (i) U.S. citizen or national, (ii) U.S. lawful, permanent reputed company (aka green card holder) reputed company • reputed company discovers, develops, and commercializing novel therapies for the treatment of cancer. It was founded in 1991, and is headquartered in reputed company, Utah, USA, with a workforce of 1001-5000 employees. Its website is http://www.myriad.com. Apply tot his job Apply To this Job