Associate Director, Cell-Based Potency Assays

Location
Emeryville, CA, United States
Posted
Nov 16, 2020
Ref
944842934
Hotbed
Biotech Bay
Required Education
Associate Degree
Position Type
Full time

4DMolecular Therapeutics (4DMT) is a gene therapy company with a transformative discovery platform—Therapeutic Vector Evolution—that enables our “disease first” approach to product discovery and development, thereby allowing us to customize our AAV vectors to target specific tissue types associated with the underlying disease.

4DMT is focused on attracting and retaining the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers uniquely generous benefits and provides challenging opportunities for career development. Join us in creating the ultimate gene therapy products to cure genetic diseases in children and adults. 4D Molecular Therapeutics headquarters are located in Emeryville, CA.

GENERAL SUMMARY:

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 AAV-based 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 (CRO, CDMO). This is a CMC and not R&D position. The AD will have a major strategic role in setting corporate direction and strategy for our bioassay and potency assay approach, as well as a key operational role in day-to-day science and testing.

RESPONSIBILITIES:

  • 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

 


QUALIFICATIONS:

 

 

  • Education:
  • PhD in a relevant area of specialization (biological sciences, cell biology, molecular biology, virology)




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  • Experience:
  • 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




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  • Skills:
  • 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

 


4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities