Principal Scientist, Potency Assay
The Seagen Process Sciences Bioassay Development group is seeking an experienced and highly motivated Principal Scientist 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 of regulatory submissions for clinical and marketing applications.
- Manage and guide Scientists and Research Associates in the development, optimization and qualification of novel in vitro potency assays intended for lot release, stability-testing and characterization of antibodies and antibody-drug conjugates (ADCs) in support of clinical- and commercial-phase programs
- Represent the Potency Assay function on various program and cross-functional-functional initiative teams. This role calls for close collaboration with other functional groups within and outside of Process Sciences including Research and Quality
- Identification and implementation new technologies and innovative approaches to measure the potency of Seagen’s pipeline molecules that incudes, but is not limited to monoclonal antibodies, multi-domain proteins, and ADCs.
- Contribute to the strategy for developing mechanism of action (MOA)-based assays to support program needs 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
- Motivate and develop staff for scientific growth and career development. Cultivate and foster scientific and technological innovation
- Promote operational excellence, team building and collaboration
- PhD. with 5+ years, or M.S. with 14+ years of relevant experience in industry setting.
- Excellent understanding of MOA for therapeutic antibodies. Understanding of the regulatory requirements for the safety and efficacy testing of large molecule clinical drugs
- Extensive hands-on experience with the design, development, optimization and qualification of potency assays that reflect the MOA of antibody, ADC and other drug modalities for relative potency determination. Such assays include but are not limited to cytotoxicity assays, binding ELISAs, homogeneous binding assays (AlphaLISA and TR-FRET), flow cytometry, Octet, proliferation, phosphorylation and reporter assay, etc.
- Experience in the use of live cell imaging systems and high-throughput liquid-handling systems is strongly desired
- 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 with 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
- Experience in leading and developing diverse, high-performing teams
- Support the creation and implementation of best practice guidelines, digitals tools and infrastructure
- Strong written and verbal communication skills
- Strong interpersonal skills and the ability to work in a multi-disciplinary team environment
- 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.