Overview

JOB DESCRIPTION

The Sr Biopharma Scientist supports verification and validation activities for molecular diagnostic products to be used in investigational studies that are 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.

Responsibilities

• Develop comprehensive and strategic assay analytical validation plans required to support regulatory agency submissions from initial development activities through product commercialization (e.g. inclusive of IDE through sPMA/IVDR submissions) to align with regulatory agency expectations.
• Establish standard analytical validation strategies, procedures and best practices to maintain consistency across new development projects (e.g. IDE/IUO)
• Design, plan, write, and lead validation/verification studies with a focus 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.
• Support applicable requests for business/project proposals, e.g., new CDx intended uses with pharmaceutical partners.
• Support analytical validation study queries requested by regulatory agencies.
• Identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.
• 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.
• 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 team-work to achieve company/project goals and timelines.
• Ability to lead and work independently. Attention to detail and accuracy.
  
  

Physical Requirements

Lifting Requirements – light work or exerting up to 20 pounds of force frequently. Physical Requirements – stationary positioning, moving, operating, ascending/descending, communicating, observing, pushing or pulling, and reaching. Use of equipment and tools necessary to perform essential job functions.

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.