THE OPPORTUNITY
Vir Biotechnology is seeking an experienced Director, Bioanalytical Science to provide scientific, technical, and regulatory leadership and expertise to develop, validate and implement testing solutions in support of Vir Bio’s research and development programs. You will support development and implementation of analytical methods for pharmacological (PK, PD, and ADA) assessments to advance research, pre-clinical, and clinical stage programs. Lead collaborations and planning with internal cross-functional teams as well as external contract research organizations (CROs) to execute analytical activities in accordance with corporate scope, timing, and budget. Support regulatory filings and correspondences as author and reviewer.
This role is based at our San Francisco headquarters, with an expectation of at least three days per week in the office.
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 organizatio
- Train senior scientists and associate scientists in lab techniques, data analysis, project management, people management, regulatory requirements and documentation
- Assist 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
