Location: San Diego, CA
HireMinds is seeking your talents in Analytical Development to add to San Diego based biotech in the AAV Gene Therapy space. They're working on next-generation AAV gene therapy, addressing limitations and overcoming barriers to bring better therapies to market.
You'll work in collaboration with research teams as well as process development and manufacturing, bringing your subject matter expertise in a variety of analytical methods/testing in support of preclinical and clinical programs.
• Lead the development and execution of analytical methods for the release and characterization of AAV gene therapy products, in process controls, and starting materials for early phase clinical development
• Develop and optimize testing methods and AAV based process development activities including: viral genome titer, capsid titer, cell-based potency, SDS-PAGE, residual impurity characterization
• Hands-on execution of standard viral vector characterization assays including: ddPCR (must have), qPCR, SDS-PAGE, ELISA, Western blots, Capillary Electrophoresis, Analytical Ultracentrifugation, HPLC and cell- based potency assays and infectivity assays
• Identify, evaluate, and implement novel analytical technologies
• Participate in the writing and review of method qualification protocols to ensure compliance with regulatory guidance and standards
• Ideally, Ph.D. with Post-Doctoral training and 2 + years industry experience in Biochemistry, Cell and Molecular Biology, Genetics or related discipline.
• Will also consider more junior scientist withPh.D. OR a Master’s degree with 5+ years of relevant experience
• Experience working with viral vectors for gene therapy and with contract research or manufacturing organizations (CMOs) is desired
• Experience in analysis and use of statistical methods in the application and design of experiments is a plus
• Ability to digest latest industry advancements in gene therapy technologies and adapt applicable methods to in-house capabilities and lab process
• Excellent written and verbal communications skills, and the ability to present and defend positions and approaches critical to program progression and success.
• Enthusiasm and ability to impart it upon teams that will work to help develop novel therapies for patients
• Adaptability and eagerness to troubleshoot or adjust to scientific changes as necessary in an evolving biotech environment