Analytical Development Scientist - Protein Chemistry

Virbiotechnologyinc; San Francisco (CA); On-site; USD 77,000 - 96,000; Full time

Job summary

Vir Biotechnology, Inc. seeks a Temporary Staff analytical chemist to support characterization of therapeutic molecules across a broad modality at various clinical stages.

The role is based in San Francisco with a requirement of in-office presence for at least four days per week. The candidate will support analytical development labs, including a mass spectrometry facility, and contribute to method development, product characterization, and regulatory filings.

Qualifications

• 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.
• 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

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

Skills

Analytical Chemistry

Mass Spectrometry

Protein Characterization

HPLC/UHPLC

CE-SDS

iCIEF

Data Analysis

Regulatory Submissions

Method Development

CRO/CMO Collaboration

Education

PhD in Analytical Chemistry

MS in related field

BS with 6+ years experience

Tools

Mass spectrometry instrumentation

UHPLC system

iCIEF instrument

Analytical data software

Job description

Vir Biotechnology, Inc. seeks a Temporary Staff analytical chemist to support characterization of therapeutic molecules across a broad modality at various clinical stages.

The role is based in San Francisco with a requirement of in-office presence for at least four days per week. The candidate will support analytical development labs, including a mass spectrometry facility, and contribute to method development, product characterization, and regulatory filings.