Senior Scientist I, Drug Product and Device Development
Vir Biotechnology, Inc.
Full-time
Remote friendly (San Francisco, CA)
United States
$158,000 - $199,000 USD yearly
Clinical Research and Development
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Role Summary
Senior Scientist I to help advance Drug Product and Device Development. Lead formulation development for liquid and lyophilized formulations across biologic modalities, support for clinical-stage process development and manufacturing, and representation on cross-functional program teams. Role combines technical execution with leadership responsibilities in a San Francisco office.
Responsibilities
- Scientific leadership of formulation development and process optimization for parenteral dosage forms of monoclonal antibodies and biologics, ensuring robustness, stability, and scalability
- Design and execute in-house laboratory studies, including formulation screening, in-use stability studies, and analytical characterization, leveraging DoE and statistical methods
- Provide technical direction and oversight for internal and external drug product development and manufacturing activities, including data review, troubleshooting, and risk assessment
- Lead technical transfer of manufacturing processes at contract manufacturing organizations, managing cross-functional alignment and addressing challenges
- Author and review high-impact technical reports, regulatory submissions, and scientific publications, ensuring clarity, accuracy, and regulatory compliance
- Represent Drug Product and Formulation and Device Development on cross-functional program teams, contributing to strategy, timelines, and issue resolution with stakeholders from clinical, process development, analytical, quality, and regulatory
- Ensure consistent scientific oversight for data generated by internal teams and external partners, upholding best practices and industry standards
- Drive continuous improvement initiatives and implement new technologies or methodologies to strengthen group capabilities
Qualifications
- PhD with 5+ years, Master’s with 8+ years, or Bachelor’s with 10+ years in Biosciences, Pharmaceutical Technology, Biochemistry, Chemistry, Chemical Engineering, or related discipline
- Demonstrated expertise in formulation and drug product development for monoclonal antibodies and biologics; lyophilization and prefilled syringe development strongly preferred
- Proficiency in experimental design (DoE), data analysis, and use of statistical programs for formulation screening and optimization
- Strong working knowledge of analytical methods supporting formulation assessments
- Solid understanding of pharmaceutical development, particularly related to biological drug development
- Experience authoring development reports, batch records, SOPs, regulatory filings, or similar documents
- Experience representing Drug Product and formulation on inter-disciplinary teams and with external collaborations
- Experience leading technical projects and mentoring junior team members
Skills
- Analytical method development and validation
- DoE and statistical analysis
- Cross-functional collaboration and technical leadership
- Technical transfer and project management
Education
- PhD, or Master’s or Bachelor’s degree in related discipline as specified