Role Summary
Senior Scientist I, Drug Product and Device Development at Vir Biotechnology. The role provides technical leadership for the development of liquid and lyophilized formulations across multiple biologic modalities, supporting clinical-stage process development and manufacturing initiatives. You will serve as a scientific representative for Drug Product on cross-functional program teams, collaborating across departments and external partners to ensure the successful progression of pipeline assets from early discovery through late-stage development. This role is located in our San Francisco headquarters with an expectation of at least 3 days per week in 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 advanced experimental designs (DoE) and statistical methods
- Provide technical direction and oversight for internal and external drug product development and manufacturing activities, including data review, trouble-shooting, and risk assessment
- Lead technical transfer of manufacturing processes at contract manufacturing organizations, managing cross-functional alignment and proactively 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, actively contributing to strategy, timelines, and issue resolution in collaboration with clinical, process development, analytical, quality, and regulatory stakeholders
- Ensure consistent scientific oversight for data generated by internal teams and contract research/manufacturing organizations, 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’ experience, in Biosciences, Pharmaceutical Technology, Biochemistry, Chemistry, Chemical Engineering, or a related discipline
- Demonstrated expertise in formulation and drug product development for monoclonal antibodies and biologics required; hands-on experience with 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
- Possess a solid understanding of pharmaceutical development, particularly as related to biological drug development
- Experience authoring development reports, batch records, SOPs, regulatory filings, or other documents
- Previous experience representing Drug Product and formulation on inter-disciplinary teams and with external collaborations
- Experience leading technical projects and mentoring junior team members