Analytical Development Associate Scientist, Biological and Cell-Based Assays
Vir Bio is seeking an experienced biological assay scientist to conduct assay development, qualification, tech transfer, 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 oversight 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.
- Assay development, troubleshooting, transfer, and implementation of cell-based and other functional methods for both process characterization and release testing.
- Perform troubleshooting and evaluation of cell based methods, and data generated by internal and contract labs.
- Participate in the design and startup of development and QC laboratories.
- Support analytical method lifecycle activities including assay transfer, design of qualification protocols, assay maintenance programs, and developing assay controls and trending programs.
- 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, and raw materials programs.
- Experience developing assay methodologies in some or all of the following: viral titer assays, cytotoxicity, ADCC, ADCP, and CDC assays.
- Experience with immuno-assays such as ELISA, ELISPOT, and Flow Cytometry.
- Background in biological therapeutics such as viral vectors, vaccine production, cell therapy, or antibodies.
- Strong background in developing methods for use in Quality Control or other regulated environments.
- Experience in analytical method lifecycle (assay transfer, qualification and maintenance) is preferred.
- Understanding of FDA, ICH, and EP or other regulatory agency guidance associated with functional potency methods is a plus.
- Technical writing skills and experience authoring development reports, SOPs, regulatory filings, or other documents.
- 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 8+ years, or PhD and 1-4 years experience in Analytical Development, prior experience working in, or directly with, QC preferred.