Analytical Development Scientist, Molecular Biology

07/31/17

Vir Bio is seeking an experienced molecular biologist to conduct assay development, tech transfer and qualification, and to 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. The Analytical Development Scientist will also provide subject matter expertise for quality audits, technical visits, and agency inspections. Responsibilities will also include authoring white papers and relevant sections of regulatory filings.

 

Responsibilities:

·         Develop strategies around development 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 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 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