Director, Bioanalytics
$203,000–$284,000 year
On-siteSan Francisco, California, United States
San Francisco, California, United StatesOn-siteFull Time$203,000–$284,000 yearSenior LevelBiopharmaceuticalMedium
Full TimeSenior LevelMediumBiopharmaceutical
Job Summary
Develop and optimize complex bioassays to measure development molecules, metabolites, and immunogenic responses for pre-clinical and clinical programs. Lead cross-functional teams and external CROs to execute analytical activities, manage method transfers, and ensure GxP compliance during validation. Prepare regulatory data packages, defend filings with agencies, and drive continuous improvement in systems and processes. Mentor senior scientists in lab techniques and project management while coordinating budgeting and goal-setting across research and clinical functions.
Required Qualifications
- MS or Ph.D. in Analytical Chemistry, Biochemistry, Protein Sciences, or related field
- 10+ years experience in bioanalytical development for biologics
- Bachelor's degree with 15+ years experience in bioanalytical development for biologics
- In-depth and strong knowledge of immunoassay and bioassay development
- Experience with method validation
- Large molecule method development expertise
- Hands-on experience with GLP/GxP
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
- Experience in preparing and defending regulatory filings
- Proven ability to manage and negotiate projects
- Ability to work with cross-functional teams comprised of internal and/or external contacts, including CROs
- 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
- This role is based at our San Francisco headquarters
- Expectation of at least three days per week in the office
- Applicants must currently be authorized to work for any employer in the U.S.
- Vir Biotechnology participates in E-Verify
Desired Qualifications
- Previous experience with data trending and statistical programs (JMP, MiniTab, Excel, etc.)
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