Associate Director / Director Formulation & Drug Product Development
Vir Bio is seeking an experienced scientist to lead the drug product development group and be accountable for the pharmaceutical development of all of Vir’s pipeline of products with a focus on biologics drug substance and drug product formulation development. This pipeline includes a diverse set of therapeutic modalities (antibodies, cell therapies, viral vectors, and nucleic acids). The candidate will initially work primarily with third parties (e.g., CDMOs and suppliers), while also establishing the necessary lab, analytical capabilities and staff to manage projects in-house. The director will provide cross-functional support to quality control, analytical development, process analytics, and other functions. She/he will author and/or review protocols, technical reports, and regulatory submissions to support clinical development and licensure.
- Provide technical leadership in formulation development to support pre-clinical and clinical programs at all development stages, drug product process development and drug product process characterization.
- Responsible for the design, execution and delivery of formulation and process development studies for liquid and lyophilized parenteral drug products of biologics (e.g. monoclonal antibodies, novel formats), viral vectors, and nucleic acids.
- Direct outsourced drug product development with Contract Manufacturing Organizations including budget development and invoicing, formulation development, container closure/device development and preparation of Chemistry, Manufacturing and Controls (CMC) programs for drug products in development.
- Establish a drug product formulation and processing laboratory, hire and train junior staff
- Develop and implement formulation, primary packaging (container closure system), and dosage form configurations to ensure stability, manufacturability, and reliability
- Participate in multi-disciplined project teams, and guide project and business strategies
- Facilitate collaboration with both internal and external drug product analytical teams, quality control and assurance, and manufacturing.
- Ensure that appropriate technical strategies, timelines and budgets are in place to meet clinical supply and registration needs, and that production, technology transfer and regulatory outcomes meet or exceed industry standards.
EDUCATION AND EXPERIENCE:
- M.S or Ph.D. in pharmaceutical sciences, biochemistry, chemistry or related fields
- 8+ years, of experience in protein and/or biologics formulation and drug product development
- Extensive understanding of drug degradation pathways and design of accelerated stability and excipient screening studies
- Experience operating in early stage clinical to commercial environments
- Strong biophysical and biochemical protein analytical skills
- Demonstrated technical, functional and/or project leadership experience to develop integrated short term and long term project plans for preclinical and clinical programs
The Human Resources team manages the recruitment and employment process for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.