Analytical Development Scientist, Biological and Cell-Based Assays

08/02/17

Vir Bio is seeking an experienced biological assay scientist to conduct assay development, tech transfer, and qualification/validation, 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 lifecycle programs for cell-based and other biological and functional assays to support biologic therapeutic programs such as viral vectors, cell therapies, and antibody therapies. The Analytical Development Scientist will also provide subject matter expertise for technical visits and agency inspections. Responsibilities will also include authoring reports, white papers, and relevant sections of regulatory filings.

 

Responsibilities:

·         Develop strategies around development, transfer and implementation of functional potency methods for biological therapeutics

·         Perform troubleshooting and evaluation of cell-based and other functional methods and data generated by contract labs

·         Participate in the design and startup of development and QC laboratories

·         Support method lifecycle activities for analytical methods including assay transfer, design of validation studies, designing assay maintenance programs, and developing assay controls and trending programs

·         Provide subject matter expertise for 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 potency assay methodologies such as viral titer assays, cell-based assays, flow cytometry, ELISA, Western Blot, and other immunological methodologies

·         Strong background in developing methods for use in Quality Control or other regulated environments

·         Experience in analytical method lifecycle (assay transfer, qualification, validation, and maintenance) is preferred

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

·         Background in biological therapeutics such as viral vectors, cell therapy, or antibodies

·         Understanding of FDA and EP or other regulatory agency guidance associated with functional potency methods

·         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, of experience in CMC analytical operations, including 3+ years either in a QC laboratory or working directly with QC