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:

The Principal Scientist uses expert knowledge of scientific principles and concepts to solve complex drug development problems in creative and effective ways. They serve as technical advisor to sr. management and build relationship between functional areas or external partners. They advise on patent or CMC regulatory strategies and develop approaches to resolve regulatory issues within CMC team. They demonstrate technical proficiency, scientific creativity, collaboration with others, and independent thought to support and influence teams. They establish a long-term vision of skill sets for functional areas and prioritize/allocate effort in team. They may supervise staff and would be responsible for driving the development of those employees. They develop an external presence as technical leader in the field by authoring journal articles, presenting posters at leading external scientific meetings, or as invited speaker.

Principal Responsibilities:

• Leverages scientific and technical experience in initiating new projects or bringing new scientific technologies that address important business needs. Pursues new areas of process and assay development, and manufacturing
• Establishes business practices that advance drug development and manufacturing. Develops approaches that allow resolution of discrepancies and regulatory issues
• Leads inter-departmental teams and represents department in senior management meetings
• Guides development efforts to comply with regulatory expectations. May defend position in front of regulatory agencies
• Thorough understanding of ICH and Regulatory Guidance and applies knowledge to drive regulatory strategies for development and CMC documents
• Creates a long-term vision of the skillsets needed for the group and build group towards that vision (either recruit or train). Motivates and supports the career development and technical growth of direct reports
• Authors technical summaries, white papers or publications (internal or external) which support department’s policies and goals
• May present at national/international forums or chair and/or help organize external meetings in area of expertise
• Technical advisor to senior management on risks to project
• Leads formulation assessment for early-stage and/or late-stage antibody and antibody-drug conjugate programs independently. May develop more complex formulations for late-stage or commercial programs
• Independently leads studies used to support formulation development, including evaluations of stability, clinical in-use, and forced degradation characterization
• Leads drug product manufacturing and lyophilization processes development for early-stage and/or late-stage programs independently. May lead more complex drug product process development and characterization activities for late-stage or commercial programs
• Independently supports technology transfer activities and oversees drug product manufacturing activities
• Able to oversee multiple development projects
• Represents formulation and drug product sciences on CMC teams and other cross-functional teams
• Leads group initiatives and technology development projects independently

Required Qualifications:

• Degree in Pharmaceutical Sciences, Biochemistry, Biological Sciences, Chemical Engineering or related discipline
• B.S. and 17+ years; M.S. and 14+ years; Ph.D. and 5+ years' experience
• At least half of industry experience performing protein formulation development, analytical and biophysical characterization or DP process development including lyophilization processes development, technology transfer to CMOs, DP CMO management
• Demonstrated protein formulation development or DP process development experience for clinical stage programs or commercial programs
• Excellent understanding of analytical and biophysical protein characterization, for example, HPLC, CE, icIEF, CEX, SDS-PAGE, AUC, DSC, CD, FTIR, Fluorescence
• Broad subject matter expertise in multiple technical areas of formulation or DP process development; working knowledge of both
• 5+ years supervisory or leadership experience
• Proven ability to lead cross-functional development teams
• Extensive experience in support regulatory submission
• Proven ability to provide strategic contribution

Preferred Qualifications:

• Hands-on experience of DP administered via multiple routes (e.g. SubQ)
• Proven experience authoring or reviewing global regulatory submission sections.
• Statistical software use, such as JMP

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.

The hiring pay range for this position is $149,000 to $192,500 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.

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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