Scientist II – Analytical Development – Protein Chemistry
| Company | Vir Biotechnology |
|---|---|
| Location | San Francisco, CA, USA |
| Salary | $134500 – $169500 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Mid Level, Senior |
Requirements
- Ph.D. in Analytical Chemistry, Biochemistry, or related fields with 3+ years (or MS with 6+ years, or BS with 7+ years) of relevant experience in analytical development and characterization of protein therapeutics in the biotechnology industry
- Knowledge and hands-on experience in state-of-the-art protein mass spectrometry techniques (instrumentation and data analysis software)
- Technical expertise and hands-on experience in characterization of biologics and associated impurities with U/HPLC, CE-SDS, and iCIEF assays
- Experience with method transfer and method qualification/validation at CROs
- Ability to trouble-shoot method-related issues at CMOs and CROs
- Knowledge of ICH guidelines and phase-appropriate best practices for method development and qualification activities
- Experience authoring/reviewing development reports, test methods, and regulatory filings
Responsibilities
- Hands-on analytical lab support for process development, formulation development, analytical methods development, and product characterization for projects at various clinical stages
- Perform all relevant analytical testing and report results in collaboration with the process development and drug product teams
- Apply mass spectrometry techniques and other analytical methods to support characterization of Vir products
- Stay current with emerging trends in protein or oligonucleotide analytics and introduce new technology to enhance workflow and capabilities
- Work cross-functionally within CMC with process and formulation development, QC and QA to meet program deliverables
- Perform forced degradation, comparability, structure-activity relationship studies to evaluate Vir products (e.g., for aggregation, charge variants, post-translational modifications, etc.), and perform CQA assessments
- Manage method development and characterization testing at external partners by providing technical review of protocols, reports, data analysis, and troubleshooting method-related issues
- Draft and review relevant sections of global regulatory filings
- Author study protocols, development/qualification reports, test methods, relevant sections of regulatory submissions, and responses to agency questions
Preferred Qualifications
- Previous experience on oligonucleotide mass spectrometry analysis is a plus