Scientist I, Analytical Development - Protein Chemistry (Temporary)

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. 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.

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 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

WHO WE ARE AND WHAT WE OFFER

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.

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.

This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.

Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology. Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.

For hires based in the United States, Vir Biotechnology participates in E-Verify.

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