Associate Director (Potency Assays), Emeryville, CA
The position of Associate Director (AD), Potency Assays, will lead the development and optimization of cell-based assays and bioassays for the lot release, characterization, and stability and formulation assessment of gene therapy drug substance and drug product. The successful candidate will be experienced with development and validation of in-vitro potency assays and will drive the phase-appropriate method development, optimization, qualification and tech transfer. He/She will have leadership to manage a growing group of scientists and research associates and manage internal (including pre-clinical and clinical bioassays, PD, and Quality) as well as external collaborations.
• Key driver to develop, optimize, and qualify/validate phase-appropriate potency assays/lot release assays and broad spectrum of cell-based characterization assays (including immunoassays, nucleic acid-based assays, enzymatic assays, image-based based, among others) on thorough understanding of the scientific background of the products, applicability of the emerging or existing bioassay platforms and phase-appropriate GMP requirements for AAV based gene therapy product
• Responsible for the cell-based assays supporting formulation, stability, and process development studies as well as GMP release methods
• A strong scientific leader who can independently design, execute, and guide effective experiments with clear goals of answering key questions to drive assay development and troubleshooting in a very face paced environment. Interprets data and effectively communicates information or risk mitigation strategies that drive critical decisions in CMC department
• Authors technical reports and SOPs and authors relevant sections of regulatory filings and responses
• Manages and provides technical expertise to Research Associates and/or Scientists in an assay development as well as routine testing efforts
• Serves as a scientific liaison for outsourced assay development, technology transfer and data management in a CRO or CMO/CDMO environment
• Works closely with the pre-clinical and clinical bioassay teams to advise and support GXP bioassays on human and pre-clinical samples for safety, biodistribution, and efficacy
• Expected to be informed on matters of state-of-the-art or innovative technologies that advance AAV characterization and integrate within the department
• PhD in a relevant area of specialization (biological sciences, cell biology, molecular biology, virology)
• 6+ years of industry within the Biotech or similar industry
• GxP experience in analytical method development and qualification under ICH/FDA guidelines is required, as is experience in a CMC group (QC/Analytical Development)
• Demonstrated experience with potency assay development for biologics or gene therapy products is required.
• Demonstrated leadership and track record of successfully developing different spectrum of bioassays by utilizing appropriate methodologies (i.e cell imaging systems, flow cytometry, qPCR, ddPCR etc)
• Must have thorough understanding of cell biology required for development of robust cell-based assays
• Thorough understanding of developing phase-appropriate potency assays using parallel line analysis
• Good understanding of high-content imaging system and image analysis is preferred
• Experience in writing SOPs, developmental and technical reports, contributions to regulatory submission documents to support CMC efforts
• Ability to bring in and assess value-added platforms based on special needs associated with characterization of the gene therapy drug products
• Experience building and leading teams and labs is desirables
• Strong verbal and written communication skills and effective interpersonal, technical discretion and troubleshooting skills are essential
• Must be a team player, strong critical thinker, exhibit a willingness to meet project timelines and multitask effectively in a dynamic fast-paced environment under challenging timelines
• Demonstrated history of working independently and leading teams while managing multiple projects
• Strong attention to detail supported by excellent time management and organizational skills
• Proficient or familiar with Microsoft based Windows programs: Word, Excel and PowerPoint as well as analytical software such as Softmax Pro and statistical software such as GraphPad, Minitab, JMP or Spotfire
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
Apply on company website