Vir Biotechnology is looking for an experienced Associate Director to join Drug Product Process Development and Formulation group. The position includes developing lyophilized and liquid formulations for multiple modalities in biologics as well as supporting clinical stage process development and manufacturing.  This position encompasses early and late-stage drug product development cycles.  The successful candidate will conduct lyophilized formulation development for Vir molecules both internally and with contract manufacturing organizations.  Responsibilities will include driving the technical aspects of formulation development, manufacturing, tech transfer, and scientific oversight of drug product and process data generated internally and with partner organizations.

This role is located in our San Francisco headquarters with an expectation of 4 days per week in office.

WHAT YOU'LL DO

• Develop robust, stable and effective liquid and lyophilized formulations for monoclonal antibodies
• Support the development of manufacturing processes for parenteral dosage forms of liquid and lyophilized biologics for the clinic and market
• Perform lab work in-house as needed to support liquid and lyophilized monoclonal antibody formulation and manufacturing process development activities
• Support technical transfer of manufacturing process from development to clinical and commercial contract manufacturing organizations
• Represent the CMC organization as the subject matter expert in lyophilized pharmaceutical development
• Collaborate with clinical, drug substance process development, analytical and quality groups to maintain project timelines
• Coordinate formulation and analytical resources as needed, including those provided by production/manufacturing, quality control, quality assurance, supply, regulatory affairs
• Provide lyophilization subject matter expertise to support regulatory submissions and technical reviews
• Author technical reports, regulatory submissions, and white papers, as needed
• Work cross-functionally to support other areas of the CMC Analytical organization, such as the stability and raw materials programs
• The candidate must be able to apply advanced technical principles, theories and concepts to lyophilized drug product development
• Knowledge and familiarity with analytical methods for formulation screening of complex biological systems is preferred
• Experience with drug device combination products is a plus

 WHO YOU ARE AND WHAT YOU BRING

• Bachelor’s Degree with 12+ years’ experience, master’s degree with 10+ years’ experience or PhD with 7+ years in Biosciences, Pharmaceutical Technology, Biochemistry, Chemistry, Chemical Engineering or a related discipline
• Must possess a solid understanding of pharmaceutical development, particularly as related to lyophilized biological drug development
• Must possess experience with formulation and drug product process development with lyophilized monoclonal antibodies
• Technical writing skills and experience authoring development reports, batch records, SOPs, regulatory filings, or other documents
• Ability to work in a multi-disciplinary team environment, meet deadlines, and prioritize work
• Strong written and verbal communication skills, and familiarity with representation on inter-disciplinary and cross-functional teams