Seagen

Principal Scientist/Associate Director, Potency Assay

Technical Operations & Process Sciences - Bothell, United States

Description

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary

Interested in making a meaningful difference in people’s lives? Join a dynamic, diverse and growing team dedicated to developing transformative therapies that are revolutionizing cancer care. The Seagen Process Sciences Potency Assays 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 establishing assay strategies, platform Potency assays and the assessment and implementation of novel technologies. This individual will also be responsible for 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. The ideal candidate should be comfortable in working in a fast-paced environment and have a proven track record of providing leadership in the development and implementation of potency assays that are compliant with USP/ICH requirements.

Principal Responsibilities:

• 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

Qualifications:

• 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.

Education

• Principal Scientist - PhD. with 5+ years, or M.S. with 14+ years of industrial experience.
• Associate Director - Ph.D. and 8+ years, M.S. and 17+ years or B.S. and 20+ years of industrial experience. 5 + years supervisory or leadership experience.

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.

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 05/20/2021