A Venture Capital-backed Cell and Gene Therapy startup is seeking an exceptional candidate to join our Vector Process Development Team in the greater Los Angeles area. This well-funded company is led by an experienced executive team with a history of successful startups in biotechnology arena. The successful candidate will be responsible for generating a team in the development of analytical methods for assessing viral vector process and product development to support ex vivo transduction of human primary cells in support of clinical manufacturing.
· Establish and lead the vector process analytical capabilities across process development for our products.
· Recruit and manage a team of Analytical Process Scientists
· Establish methods for characterization of process and product and final product release for vector and gene-modified cell therapy products
· Lead the technical transfer of test methods to collaborators and CDMOs
· Drive the development ofQC-friendly early-stage product release assays and new analytical methods.
· Establish and maintain strong collaborative relationships with company’s R&D and Quality.
· Contribute to regulatory filings.
Requirements,Knowledge, Skills and Abilities:
· PhD in immunology, microbiology, molecular biology or other related discipline with a minimum of 5years of industry experience in analytical development for cell and gene therapies (an equivalent combination of education and experience may be considered).
· Minimum of 5 years of experience working with lentiviral vectors; experience with AAV vectors also valued
· Proven leadership experience with recruiting, managing and developing teams
· Industry experience with development of analytical methods, such as qPCR, qRT-PCR, ddPCR, ELISA, cell-based potency assays, flow cytometry, RNAseq, and gel electrophoresis.
· Experience developing assays for Quality Control testing of drug substance or drug product
· Ability to work in a fast-moving dynamic small company environment.
· Outstanding written and oral communication skills are essential
· Ability to present thoughts clearly and concisely to a wide variety of stakeholders including senior management
· High sense of integrity and professionalism and the ability to work well in a cross functional team environment