Scientist II, Analytical Development (Protein Chemistry)
San Francisco, United States
Job Description
Vir Biotechnology seeks an experienced analytical chemist to lead 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.
This role is located in our San Francisco headquarters with an expectation of at least 4 days per week in office.
WHAT YOU'LL DO
- 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
WHO YOU ARE AND WHAT YOU BRING
- 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). Previous experience on oligonucleotide mass spectrometry analysis is a plus
- 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
WHO WE ARE AND WHAT WE OFFER
The expected salary range for this position is $134,500 to $169,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Vir Biotechnology's compensation and benefits are aligned with the current market and commensurate with the person’s experience and qualifications. All full-time employees receive a package that includes compensation, bonus and equity as well as many other Vir Biotechnology benefits and perks such as health and welfare benefit plans, non-accrual paid time off, company shut down for holidays, commuter benefits, childcare reimbursement, education reimbursement, 401K match and lunch each day in the office.
Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to any legally protected characteristics.
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