Quality Control Sr. Scientist, Virology

07/31/17

Vir Bio is seeking an experienced virologist for a strategic and tactical role overseeing the design and implementation of systems to support viral safety and other viral-related QC analytics. This role will involve both laboratory work and providing QC representation on cross-functional project teams, and may include management of lab personnel. This individual will provide guidance on adventitious agents testing strategies for raw materials, viral therapeutics, and intermediates. He or she will implement and execute method life cycle programs for viral assays including qualification, transfer, training, validation, and maintenance. The QC Scientist will also provide subject matter expertise for quality audits, technical visits, and agency inspections. Responsibilities will also include authoring white papers and relevant regulatory filings.

 Responsibilities:

·         Develop strategies around viral adventitious agents testing of viral and other biological therapeutics, critical raw materials, and intermediates

·         Perform troubleshooting and evaluation of methods and data generated by contract labs

·         Participate in the design and startup of QC laboratories

·         Design and review test panels and specifications for biological drug products, ancillary materials, intermediates, cell and viral banks, and critical raw materials

·         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 assay validation and lifecycle management, management of contract organizations, stability, and assay development.

 

Qualifications:

·         Technical proficiency with virology and safety methods including cell-based infectivity assays, co-culture methods, PCR, and sequencing

·         Strong scientific and quality/regulatory knowledge in viral adventitious agents testing of raw materials, intermediates, and final product

·         Strong background in GMP compliance of Quality Control, with experience in analytical method lifecycle

·         Technical writing skills and experience authoring validation protocols, reports, and other regulatory filings

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

·         Thorough understanding of FDA and EP or other regulatory agency guidance associated with adventitious agents testing of biological products

·         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 12+ years, or PhD and 5+ years, in GMP analytical operations, including 2+ years in a QC laboratory or regulated laboratory setting