Associate Director, Bioassay Development
The Seagen Process Sciences Potency Assay 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 development. 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, associates and analysts responsible for developing bioassays in support of early and late phase development programs. Provide guidance to design, develop, optimize, qualify and/or validate and transfer novel cell-based bioassays and immunoassays for characterization of antibodies and antibody-drug conjugates (ADCs) in conformance with cGxPs.
- Evaluate and implement new technologies for binding and cell-based assays for biological modalities such as monoclonal antibodies, multi-domain proteins, and ADCs. Cultivate scientific and technology innovation.
- Represent the Bioanalytical Development function on project teams or cross-functional teams. The role calls for close collaboration with Research, Development, QC and other functional groups.
- Contribute to the strategy for developing 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
- Provide technical oversight and strategic input for bioassay. 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.
- Ph.D. 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 novel bioassays and immunoassays across multiple platforms and technologies (e.g. ELISA, MSD, flow cytometry and cell based-proliferation, phosphorylation, reporter and cytotoxicity assays).
- 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 mechanism-of-action for therapeutic antibodies. Understanding of the regulatory requirements for the safety and efficacy testing of large molecule clinical drugs
- Demonstrated leadership capabilities to develop a highly skilled and performing team.
- Strong written and verbal communication skills
- Experience working in cross-functional teams
- 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, Seattle Genetics 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 Seattle Genetics, please visit www.seattlegenetics.com.
Seattle Genetics 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.