Principal Scientist Impurity Assay at Seattle Genetics in Bothell, Washington

Job Description:

Seattle Genetics



Technical Operations & Process Sciences ⋅ Bothell, Washington

Description

Position at Seagen
Summary:
The Principal Scientist 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 of skill sets 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. They will develop an external presence as technical leader in the field.
Principal Responsibilities:

• Drive technology assessment/development for impurities and align it to overall goals of the TOPS organization
• Manage direct reports within the Impurity Assay group. Integrate activities of this group to develop process impurity assays and conduct impurity characterizations to support all pipeline programs
• Represent Impurity Assay group on GTD teams leading impurity specific activities, regulatory input and impurity control strategy
• Take on role of Analytical lead role on GTD teams
• Collaborate with members of the Impurity Assay group, Pharmaceutical Sciences, Bioprocess Development and Analytical Sciences, Quality, and CMC regulatory
• 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:

• M.S and 14+, or Ph.D. with 5+ years of industrial experience
• Supervisory or leadership experience
• In depth experience with ELISA, qPCR, enzymatic methods
• Experience with laboratory automation
• Understanding of regulatory requirements for biologics
• Industry experience working on cross-functional CMC teams
• Great problem-solving skills
• 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 visitwww.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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