Seagen
Associate Director, Impurity 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
Do you want the opportunity to provide scientific and technical leadership in a growing function within Seattle Genetics? Through strategic thinking and strong leadership, you will be able to directly contribute to establishing the framework that will support all current and future drug product development activities for Impurity Assay group. This is an excellent opportunity to apply your expertise to drive strategic direction in a creative and highly collaborative environment. We’re looking for a leader that will own initiatives, have a focus on excellence, and influence the larger organization. The Associate director will serve as the Impurity Assay group lead on program teams where they will provide technical and strategic guidance to the team and support regulatory filings. This individual will help establish long term vision for the impurity assay group which is focusing on assay development and impurity characterization for Seagen (SGEN) antibodies and antibody-drug conjugates (ADCs). They will supervise staff and drive development of those employees and lead cross-functional teams. They will develop an external presence as technical leader in the field and help to advance industry best practices.
Principal Responsibilities:
- Drive technology assessment/development for impurities and align it to overall goals of the TOPS organization
- Provides technical, managerial, and strategic leadership within the group to develop process impurity assays and impurity characterizations strategies to support all pipeline programs
- Represent Impurity Assay group on program teams leading impurity specific activities, regulatory input, and impurity control strategy
- Contribute to the control strategy for process impurities and contribute to regulatory submissions
- Collaborate with groups across the Seagen organization
- Provide strategic contribution to the development strategy, practice, and operations beyond functional area. Lead or participate cross-functional taskforces and initiatives
- Review or author relevant CMC sections of regulatory submissions. Serve as SME or provide strategy guidance for key regulatory interactions
- External outreach and influence: participate and drive changes through industry workgroups or professional societies
- Motivate and develop staff, encourage personal growth and operational excellence
Qualifications:
- B.S. and 20+ years; M.S. and 17+ years Ph.D. and 8+ years
- Supervisory or leadership experience
- In depth experience with ELISA, qPCR, enzymatic methods
- Experience with laboratory automation
- Demonstrated expertise in small molecule/biologics development within the pharmaceutical industry
- Strong interpersonal skills/communication skills and experience with cross-functional mentorship and influence to enable execution of complex global projects
- Provide support establishing department/functional area strategy and demonstrate people management skills
- Understanding of regulatory requirements for biologics
- Industry experience working on cross-functional CMC teams
- Strong interpersonal and organization skills
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.
Apply:
Seagen
Seagen is an Equal Opportunity Employer
Submitted: 05/20/2022
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