Vir Bio is seeking an experienced biochemist to conduct protein and antibody assay development, tech transfer and qualification. This individual will provide scientific oversight of the methods at satellite labs and contract testing organizations. This role will involve laboratory work as well as providing representation on cross-functional teams, and may include management of lab personnel. This individual will develop, implement and execute methods to characterize ancillary raw materials, critical reagents, process development material and other biological therapeutic programs. The Analytical Development Scientist will also provide subject matter expertise for quality audits, technical visits, and agency inspections.
· Develop assay panels to characterize ancillary raw materials, critical reagents, process development material and other biological therapeutic targets.
· Perform troubleshooting and evaluation of protein/antibody methods and data generated by contract labs
· Work cross functionally to support other areas of organization such as quality control, assay development and process development groups to accelerate understanding of key targets.
· Provide subject matter expertise for quality audits, technical reviews, and agency inspections
· Author technical report, test methods, validation protocols/reports and white papers, as needed.
· Experience independently developing protein and antibody assay methodologies, such as H/UPLC, mass spec, and gel-based assays.
· Strong background in developing methods for transfer to Quality Control
· Technical writing skills and experience authoring development reports, SOPs, regulatory filings, or other documents
· Experience developing assays for Ancillary Materials and drug product residuals.
· Understanding of FDA and EP or other regulatory agency guidance associated with release assays is strongly preferred.
· Strong understanding of fit-for-purpose phase appropriate method requirements.
· Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.
· Strong written and verbal communication skills, and familiarity with representation on inter-disciplinary and cross-functional teams
· Education and Experience:
· BS/MS and 10+ years, or PhD and 3+ years, of experience in assay development in the biotech field.
· Preferred experience developing QC suitable release assays.