Facebook pixel

Director – Formulation and Drug Product Development
Posted on 8/19/2022
INACTIVE
Locations
Remote • United States
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Leadership
Requirements
  • Extensive understanding of drug degradation pathways and design of accelerated stability and excipient screening studies
  • Experience operating in both early and late-stage cGMP clinical programs
  • Significant proficiency in drug product processing unit operations including filling, lyophilization, capping
  • Strong biophysical and biochemical protein analytical skills
  • Demonstrated technical, functional and project leadership experience to develop integrated short term and long-term project plans for preclinical, clinical and commercial programs
  • Proven track record of leading scientists/engineers and managing multiple concurrent technical projects
Responsibilities
  • Provide technical leadership in formulation development to support pre-clinical and clinical programs at all development stages, drug product process development and 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
  • Work with non-clinical and clinical teams to design and execute studies to support product use and stability
  • Supervise outsourced drug product development with Contract Manufacturing Organizations
  • 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 strategies
  • Facilitate collaboration with both internal and external drug product analytical teams, quality control and assurance, and manufacturing
  • Ensure that appropriate technical strategies and timelines are in place to meet clinical supply and registration needs, and that production, technology transfer and regulatory outcomes meet or exceed industry standards
  • Authoring CMC sections for regulatory filings
Desired Qualifications
  • 20 years + (BS); 17+ years (MS); 12+ years (PhD) of experience in protein or viral vaccine formulation and drug product development is required. Experience with multiple therapeutic modalities is a plus
Vir Biotechnology

201-500 employees

Company Overview
Vir Biotechnology is a clinical-stage immunology company developing therapeutic products to treat and prevent serious infectious diseases.
Benefits
  • Comprehensive healthcare coverage
  • Employer matched 401(k)
  • Employee stock purchase plan
  • Childcare assistance
  • Tuition reimbursement
Company Values
  • Why We Work: To transform the care of patients with or at risk of serious infectious diseases throughout the world
  • Who We Are: Authenticty and Humility
  • What Drives Us: Fearless curiosity grounded in data
  • How We Act: Transparency and connection
  • When We Deliver: Determination and accountability
  • If In Doubt: Do the right thing, even when it's the hard thing