Director, Bioanalytics

What You'll Do

• Conceptualize, research, develop and optimize complex assays to measure the concentration of Vir Bio’s development molecules, including relevant metabolites, and to determine immunogenic responses (ADA) including neutralizing antibody assays
• Mentor and manage bioanalytical team developing and implementing bioanalytical assays at Vir and transferring methods and technology to Contract Research Organizations (CROs)
• Serve as Sponsor representative for transfer, maintenance, trouble-shooting and phase-appropriate qualification/validation of bioanalytical methods at CROs
• Review, edit and approve assay validation plans and reports generated at CROs. Ensure suitability for use based on study objectives, technical content, and GxP compliance
• Prepare reports and data packages and provide input for interactions with regulatory agencies
• Interact with regulatory agencies, participate in audits/inspections, and prepare draft responses as needed
• Interface with Research and clinical functions (clinical team leads, sample operations, data management, etc.) to ensure timely, high-quality support for sample analysis to meet study objectives and needs
• Work cross-functionally to strategize and coordinate goal-setting, budgeting, and process improvements
• Recommend and review proposed changes to systems, procedures, methods, and regulatory submissions
• Identify and influence continuous improvement opportunities across the organization
• Train senior scientists and associate scientists in lab techniques, data analysis, project management, people management, regulatory requirements and documentation
• Aid with CRO selection, qualification, auditing and management as needed

  Who You Are And What You Bring

  • MS or Ph.D. in Analytical Chemistry, Biochemistry, Protein Sciences, or related field with 10+ years experience or Bachelor’s degree with 15+ years experience in bioanalytical development for biologics
  • In-depth and strong knowledge of immunoassay and bioassay development and experience with method validation
  • Large molecule method development expertise and hands-on experience with GLP/GxP is required
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211) with experience in preparing and defending regulatory filings
  • Proven ability to manage and negotiate projects and work with cross-functional teams comprised of internal and/or external contacts, including CROs
  • Previous experience with data trending and statistical programs (JMP, MiniTab, Excel, etc.) preferred
  • Demonstrated ability to build and maintain teams, including hiring, training, and motivating both senior and lab-level scientists
  • Demonstrated ability to build and maintain positive and collaborative relationships with management, peers, subordinates, and externally with third-party contract organizations
  • Strong organizational skills to maintain a high level of productivity, innovation, and priority-setting to complete assignments on time and budget