Dir, Assay Development - Boston Massachusetts

Company: Disability Solutions
Location: Boston, Massachusetts
Posted On: 05/13/2024

About the Job
The Director, Assay Development will work as part of a new product team, focused on improving blood-based cancer diagnostic capabilities in areas such as cancer detection, minimum residual disease, and other related applications. This team is comprised of talent from across the Roche ecosystem, including Roche Diagnostics, Roche Pharma and Foundation Medicine, operating as a single unit.
The Director, Assay Development, leads the development of new NGS- and protein-based assays in collaboration with a cross-functional team. This position is primarily focused on leading late-stage development through commercial launch by managing laboratory and documentation activities to verify and validate product requirements, assay design, and assay performance. Responsibilities include designing and developing verification and validation studies in collaboration with the Biomarkers and Biostatistics team to ensure that assay design is fit for purpose. The incumbent collaborates closely with other members of the Assay Development team and the Laboratory Operations teams and directs program efforts from validation through design transfer.
This is a regulated position and additional information may be available from QA on the qualifications for this role pertaining to regulatory guidelines.
--
Key Responsibilities

• Lead the scientific team responsible for late-stage development and optimization of highly complex NGS workflows and protein assays.--
  
  
  
  • Supervise a team of scientists and research associates, and conduct performance reviews, development activities, and hiring.
    
  • Mentor and train team members on validation design implementation and documentation to meet quality system requirements.
    
  • Manage and author detailed protocols and reports for verification and validation studies.
    
  • Ensure that Design Control principles are followed and documented per our quality system.
    
  • Manage and delegate tasks within the department.
    
  • Design, evaluate, and coordinate projects pertinent to the assay development function.--
    
  • Maintain budgetary and operational management of assay development for projects.--
    
    
    
  • Collaborate with Project Lead, operations, technology, and product manager to define target product profile, operational specifications, and to demonstrate that the assay workflow meets these requirements.--
    
    
    
    • Manage multiple concurrent initiatives.
      
    • Execute development programs that lead to long-term, sustainable success of multiple products.
      
    • Establish and validate performance parameters, quality control, and stability specifications.
      
    • Provide oversight on product design change validation projects and timelines in parallel.
      
      
      
    • Lead assay transfer and validation activities in alignment with submissions to regulatory agencies.
      
      
      
      • Manage training and performance qualification testing during tech transfer between the development and operations teams.
        
      • Partner collaboratively with the Regulatory Affairs, Computational Biology, and Quality Assurance Teams across the enterprise to ensure that all procedural and submission documentation meets audit, compliance, and accreditation standards.
        
      • Provide key contributions to the analytical and clinical studies in the program, including but not limited to protocol development, testing, and execution.
        
      • Support the timely processing and reporting of clinical trial validation samples to internal and external collaborators.
        
      • Contribute to the planning and delivery of key analytical and clinical components of regulatory submissions, including but not limited to Pre-subs, PMA, and sPMA.
        
        
        
      • Proactively establish and grow cross-functional collaboration and partnerships.--
        
      • Present results at group meetings to external collaborators, and prepare reports for submission to regulatory agencies (FDA).
        
      • Other duties as assigned.
        
        --
        Qualifications:
        Basic Qualifications:
        
        
        
        • Bachelor's degree in Molecular Biology, Clinical Lab Science, Biochemistry, Genetics or Cancer Genetics, or related field.--
          
        • 10+ years of professional work experience in a molecular testing laboratory, diagnostic manufacturing organization and/or a diagnostics service organization.
          
        • 5+ years of management experience
          
          Preferred Qualifications:
          
          
          
          • 12+ years of working experience in industry.
            
          • Extensive experience with molecular biology techniques and an understanding of the practices and principals of NGS, including DNA-seq and target-enrichment.
            
          • Experience:
            
            
            
            • Managing a team of scientists of all levels.
              
            • Experience in product development, assay development, and clinical services.
              
            • Developing, implementing, and supporting high complexity clinical assays in a regulated
              
            • environment (such as with FDA-QSR, CLIA, CAP, ISO regulations).
              
            • Writing standard operating procedures, validation protocols, and data reports adherent to regulations.
              
            • Communicating with regulatory bodies and participating in audits.
              
              
              
            • Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one's own workflow.
              
            • Demonstrated track record of timely completion ahead of deadlines.
              
            • Demonstrated ability to work in a dynamic, fast-paced team environment.
              
            • Strong interpersonal skills in collaboration and problem solving with other departments and colleagues.
              
            • Understanding of HIPAA and importance of privacy of patient data.
              
            • Ability to work well under pressure while maintaining a professional demeanor
              
            • Excellent organization and attention to detail.
              
            • Commitment to reflect FMI's values: passion, patients, innovation, and collaboration.
              
              #LI-Hybrid More...

                  

              ---

              Register an account with us and set up job agents! We'll email you immediately when jobs like this are posted on our site.

              ---