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Associate Director, Bioassay/Potency Assay Development

Company: IowaLifeScience
Location: Bothell
Posted on: February 23, 2021

Job Description:

The Seagen Process Sciences Bioassay Development group is seeking an experienced and highly motivated Associate Director to lead the development of in vitro assays to support monoclonal antibody and antibody drug process development and manufacturing. This individual will be responsible for contributing to assay development strategies and providing technical guidance to Scientist and Research Associate staff. Additional responsibilities include representation on program and cross-functional teams and support the regulatory submissions for clinical and marketing applications.

  • Lead a group of scientists and associates responsible for developing in vitro potency assays in support of early and late phase development programs. Provide guidance to design, develop, optimize, qualify, and transfer novel cell-based potency and immunoassays to support lot release and characterization of antibodies and antibody-drug conjugates (ADCs) in conformance with cGxPs.
  • Evaluate and implement new technologies for binding and cell-based assays to measure the potency of biological modalities such as monoclonal antibodies, multi-domain proteins, and ADCs. Cultivate scientific and technology innovation.
  • Represent the Potency development function on various project teams and cross-functional teams. The role calls for close collaboration with Research, Development, QC and other functional groups.
  • Contribute to the strategy for developing Mechanism of Action (MOA)-based assays that impact program and regulatory submissions.
  • Author and review CMC sections of regulatory submissions (e.g. IND and BLA) and supportive source documents such as technical reports and risk assessments.
  • Develop talent, inspire innovation and promote team building and operational excellence.
  • Motivate and develop staff for scientific growth and career development. Foster a continuous learning environment. --Qualifications
    • PhD. with 8+ years, or M.S. with 10+ years of relevant experience in industry setting
    • Extensive hands-on experience with the design, development, optimization and qualification of cell-based potency assays to reflect the MOA of antibody and ADC candidates and relative potency determination. Such assays include cytotoxicity assays, binding ELISA's, alphaLISA's, flow cytometry, cell based-proliferation, phosphorylation and reporter assay, etc.
    • Experience with current statistical approaches to evaluating potency data e.g. parallel line analysis, determination of relative potency, USP chapters on Bioassay, and design of experiments (DOE). Extensive experience in partnering in internal and external functions to transfer and implement potency assays
    • Highly competent in common software and data analysis packages e.g. SoftMax Pro, JMP, PLA software, GraphPad Prism, Microsoft Office Tools
    • Leverage external networks to stay current on industry best practices and emerging technologies in potency assay development and support improvements on existing capabilities
    • Excellent critical thinking and scientific acumen, with a demonstrated ability to analyze, interpret, and clearly communicate complex data and the impact to program and regulatory strategy
    • Proven experience in supporting regulatory submissions (INDs, BLAs, IMPDs, MAAs)
    • Demonstrated experience managing and mentoring direct reports
    • Excellent understanding of MOA for therapeutic antibodies. Understanding of the regulatory requirements for the safety and efficacy testing of large molecule clinical drugs
    • Lead and develop a diverse, high-performing team,
    • Support the creation and implementation of best practice guidelines, digitals tools and infrastructure
    • Strong written and verbal communication skills
    • Experience working in cross-functional teams --Education
      • M.S. or Ph.D. in Cell Biology, Immunology, Biochemistry, Molecular Biology or related disciplines As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com . Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

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Keywords: IowaLifeScience, Seattle , Associate Director, Bioassay/Potency Assay Development, Executive , Bothell, Washington

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