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Analytical Development Associate Scientist Molecular Biology

Company name
VIR

Location
San Francisco, CA

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Analytical Development Associate Scientist, Molecular Biology

in

San Francisco

California

Vir Bio is seeking an experienced molecular biologist to conduct assay development, qualification, and tech transfer to QC or CMO/CTL. The Analytical Development Scientist will provide scientific oversight of the methods at satellite labs and contract testing organizations. This role will involve laboratory work as well as providing representation on cross-functional teams, and may include management of lab personnel. This individual will implement and execute method development programs for molecular and sequencing assays to support viral and other biological therapeutic programs.

Responsibilities:

Develop strategies, execute, and transfer of molecular biology and sequencing methods

Perform troubleshooting and evaluation of PCR and other molecular biology methods and data generated by contract labs

Participate in the design and startup of development and QC laboratories

Support analytical method lifecycle activities including assay transfer, designing validation protocols, designing assay maintenance programs, and developing assay controls and trending programs

Provide subject matter expertise for quality audits, technical reviews, and agency inspections

Author reports and relevant sections of regulatory filings

Work cross-functionally to support other areas of the CMC Analytical organization, such as management of contract organizations, stability, raw materials programs, and assay lifecycle management.

Qualifications:

Experience developing and qualifying molecular biology assay methodologies, such as PCR and sequencing

Technical proficiency with NextGen (deep sequencing) techniques and data analysis

Strong background in developing methods for transfer to Quality Control

Technical writing skills and experience authoring development reports, SOPs, regulatory filings, or other documents

Background in viral vector products, vaccines, or gene therapy is preferred

Understanding of FDA, ICH, and EP or other regulatory agency guidance associated with molecular biology methods is a plus

Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects

Strong written and verbal communication skills, and familiarity with representation on inter-disciplinary and cross-functional teams

Education and Experience:

BS/MS and 10 years, or PhD and 3 years, of experience in CMC analytical operations, including 2 years either in a QC laboratory or working directly with QC

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