Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Our current development pipeline consists of five product candidates targeting hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis.
Vir Bio is seeking an experienced analytical chemist with extensive expertise in mass spectrometry, HPLC, and other analytical chemistry techniques. The ideal candidate will conduct development and characterization studies which support a variety of therapeutic platforms, with a focus on recombinant antibodies or siRNA and oligonucleotides. This individual will develop, implement and execute methods to characterize drug products, impurities, and degradants, as well as critical reagents, process development samples, and other biological materials. The role will include oversight of these types of activities at contract organizations. This role will involve laboratory work as well as providing representation on cross-functional teams and mentorship of lab personnel.
- Apply methodologies for characterizing recombinant antibodies and/or siRNA and oligonucleotides. These would include some or all of the following: state of the art mass spectrometry, gas chromatography, ion chromatography, capillary electrophoresis, U/HPLC, USP compendial methods.
- Conduct process and product comparability assessments to support facility and process changes during the drug development lifecycle
- Perform troubleshooting and evaluation of analytical methods and data, including assay qualification and validation, generated internally and by contract labs
- Support method transfer at contract testing labs including review of transfer protocols and associated data
- Lead a core facility focused on analytical chemistry development supporting multiple therapeutic platforms, including recombinant antibodies, oligonucleotides, and/or viral vectors.
- Work cross-functionally to support other areas of the organization such as Quality Control, Analytical Development, Process Development, and Research groups to accelerate understanding of key targets
- Provide subject matter expertise to support regulatory submissions, technical reviews, and agency inspections
- Author technical reports, regulatory submissions, test methods, validation protocols/reports and white papers, as needed
- Mentor/train junior staff on mass spectrometry and other analytical chemistry techniques
QUALIFICATIONS AND EXPERIENCE
- Must possess a solid understanding of one or more of the following: protein chemistry and biochemistry, siRNA chemistry and biochemistry, particularly as related to biological drug development.
- Extensive expertise in mass spectrometry (MS), U/HPLC, and other analytical technologies as applied to the analysis of recombinant proteins and/or oligonucleotides
- Technical writing skills and experience authoring development reports, SOPs, regulatory filings, or other documents
- Experience developing assays for characterization of drug product impurities, degradants, and process residuals
- 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.
- Ability to develop assay panels to characterize ancillary raw materials, critical reagents, process development material and other biological therapeutic targets
- Experience developing protein and antibody assay methodologies such as proteomics, peptide mapping by MS, H/UPLC, capillary electrophoresis, SEC, CEX, icIEF and/or oligosaccharide analyses is a plus
- Background in developing methods for transfer to Quality Control
- Understanding of FDA and EP or other regulatory agency guidance associated with release assays
- BS/MS and 15+ years, or PhD and 8+ years, of experience in assay development in the biotech field
VIR is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
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.