SCIENTIST, BIOASSAYS-CMC ANALYTICAL DEVELOPMENT
Vir Biotechnology (Vir) is seeking an experienced Analytical Development scientist to conduct assay development, technology transfer, qualification/validation, and to provide scientific oversight of the methods at satellite labs and contract testing organizations. The individual will develop cell-based and other biological and functional assays to support biologic therapeutics programs such as antibody therapies, viral vectors, and cell therapies. This role will involve laboratory work, including the design and interpretation of laboratory experiments, as well as providing representation on cross-functional teams, and may include mentorship of lab personnel. 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.
- Assay development, troubleshooting, transfer, and implementation of cell-based and other functional methods for both process characterization and release testing.
- 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 assay work conducted at contract organizations and satellite labs, 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.