Virbiotechnologyinc
Senior Scientist I, Drug Product & Device Development (Temporary)
San Francisco, California, United States. Posted a month ago
The role
This person will provide technical leadership for the development of liquid and lyophilized formulations across multiple biologic modalities. They will design laboratory studies and represent Drug Product on cross-functional program teams.
What you will do
- Scientific leadership of formulation development and process optimization for parenteral dosage forms
- Design and execute in-house laboratory studies including formulation screening and analytical characterization
- Provide technical direction and oversight for internal and external drug product development and manufacturing
- Lead technical transfer of manufacturing processes at contract manufacturing organizations
- Author and review technical reports, regulatory submissions, and scientific publications
- Represent Drug Product and Formulation and Device Development on cross-functional program teams
- Ensure consistent scientific oversight for data generated by internal teams and contract organizations
- Drive continuous improvement initiatives and implement new technologies
Required qualifications
- PhD with 5+ years experience, Master’s with 8+ years or Bachelor’s with 10+ years experience
- 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
- Proficiency in experimental design (DoE), data analysis, and use of statistical programs
- Strong working knowledge of analytical methods supporting formulation assessments
- Solid understanding of pharmaceutical development related to biological drug development
- Experience authoring development reports, batch records, SOPs, or regulatory filings
- Experience representing Drug Product and formulation on inter-disciplinary teams and with external collaborations
- Experience leading technical projects and mentoring junior team members
Nice to have
- hands-on experience with lyophilization
About the company
Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing medicines for serious infectious diseases and cancer.