Sr Biopharma Scientist at the Myriad Genetics Candidate site

, , United States -

Full Time

Start Date

Immediate

Expiry Date

19 Feb, 26

Salary

0.0

Posted On

21 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Molecular Diagnostics, Regulatory Compliance, Analytical Validation, Cross-Functional Collaboration, Quality System Regulations, Clinical Trials, Assay Validation, Project Management, Risk Management, Training, Documentation, Team Leadership, Communication, Design Control, GxP, ISO 13485

Industry

Biotechnology Research

Description

Overview The Sr. Biopharma Scientist supports verification and validation activities for molecular diagnostic products subject to domestic and international regulatory requirements, e.g., US FDA, Japan PMDA, EU IVDD/IVDR, and clinical laboratory regulations for the Biopharma business unit. This position is primarily responsible for developing and executing comprehensive and strategic assay analytical validation plans based on alignment with regulatory agency expectations. The role requires productive cross-functional collaborations with multiple Myriad Genetics teams (e.g., R&D, Operations, Regulatory Affairs, Quality Assurance, Software and Information Technology, Laboratory Directors) and external stakeholders (e.g., pharmaceutical partners and regulatory agencies) in support of the Biopharma business unit objectives. Responsibility 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. Qualifications Must meet one of the following education and experience requirements: 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) We take geographic location into account when determining base salary to ensure equitable and competitive compensation. EEO We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. In hiring and all other employment decisions, we prohibit discrimination and harassment on the basis of any protected characteristic, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants’ and employees’ religious practices and beliefs, as well as any mental health or physical disability needs. #BioPharma #SrBiopharmaScientist #MolecularDiagnostics #AssayValidation #RegulatoryCompliance #FDA #PMDA #IVDR #ClinicalTrials #QualitySystems #DesignControl #GxP #ISO13485 #CrossFunctionalCollaboration #PharmaJobs #BiotechCareers #HiringNow #LifeSciences #LI-KO1

Responsibilities

The Sr. Biopharma Scientist is responsible for developing and executing assay analytical validation plans in compliance with regulatory requirements. This role involves cross-functional collaboration to support the Biopharma business unit objectives.