Associate Director – Drug Product Process & Formulations
| Company | Vir Biotechnology |
|---|---|
| Location | San Francisco, CA, USA |
| Salary | $177500 – $222500 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- 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
Responsibilities
- 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
Preferred Qualifications
- Knowledge and familiarity with analytical methods for formulation screening of complex biological systems is preferred
- Experience with drug device combination products is a plus