Associate Director, Vector Analytical

Greater Los Angeles Area

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.

 

Responsibilities: 

·       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

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