Scientist I, Analytical Development - Protein Chemistry (Temporary)

About the role

Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology has exclusive rights to the universal PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company. We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best. THE OPPORTUNITY Vir Biotechnology seeks a Temporary Staff analytical chemist to support the characterization of therapeutic molecules across a broad modality of products at various clinical stages. The successful candidate will be responsible for supporting the operation of analytical development labs, including a mass spectrometry facility, and be a key member on project teams. Additionally, this individual will be responsible for hands-on analytical support for process development, method development, and product characterization studies of proteins and oligonucleotides, such as forced degradation, comparability and structure-activity relationship studies.

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

Requirements

Ph.D. in Analytical Chemistry, Biochemistry, or related fields with 0+ years (or MS with 4+ years, or BS with 6+ years) of relevant experience in analytical development and characterization of protein therapeutics in the biotechnology industry.

Skills

• Technical expertise and hands-on experience in characterization of biologics and associated impurities with U/HPLC, CE-SDS, and iCIEF assays
• Ability to collect, process, interpret, and present analytical data independently
• Knowledge and hands-on experience in state-of-the-art protein mass spectrometry techniques (instrumentation and data analysis software)
• Previous experience on oligonucleotide mass spectrometry analysis is a plus
• Ability to investigate observations in analytical data through experimental design, historical data trending, and literature review
• Experience with method transfer and method qualification/validation at CROs
• Ability to trouble-shoot method-related issues at CMOs and CROs
• Knowledge and experience on comparability study, CQA assessment, and forced degradation study is a plus
• 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

Pay

The expected hourly range for this position is $56.00 to $70.00. Actual pay will be determined based on experience, qualifications, and other job-related factors.

Schedule

This role is located in our San Francisco headquarters with an expectation of at least 4 days per week in office.