Senior Scientist Analytical Sciences
This position is responsible for leading a group of scientists within the analytical sciences department. Responsibilities include developing staff, providing technical guidance, leading product characterization, and developing strategies to increase product and process understanding. This position will partner with leadership to shape analytical CMC strategies such as manufacturing technologies, comparability, CQA control strategy, and regulatory submissions, with the end goal of developing and registering biologics products worldwide. The candidate will author/review key technical reports, as well as relevant CMC sections to support US and EU regulatory filings from IND to BLA. The position reports to the Director of analytical sciences and partners closely with other functions including, cell line and cell culture development, purification, pharmaceutical sciences, data sciences, CMC program and strategy, regulatory and quality within the Technical Operations organization.
- Lead scientists and research associates within the analytical sciences department, providing technical, managerial, and strategic leadership to the group.
- Oversee areas of analytical development including contributing to analytical development of early, late, and commercial programs, technology innovation, method development, transfer and lifecycle management, comparability, and product characterization
- Mentor analytical group member to achieve CMC team objectives
- Oversee relevant CMC sections of regulatory submissions and serve as a subject matter expert in regulatory interactions
- Drive bringing in new technological in analytical development to support company’s business objectives
- Collaborate with process and pharmaceutical development as well as data sciences to advance our understanding of the process to product quality relationship
- Encourage personal growth. Foster good teamwork and communication. Build a reputation for excellence both as an individual and as a team
- Support manufacturing activities at both internal and external manufacturing organizations. Cultivate excellent working relationship with stakeholders to deliver successful manufacturing campaigns
- Collaborate effectively with departments within and outside of TOPS organization
- SME and extensive experience in the analytical development space. Including a solid knowledge of protein chemistry and analytical techniques
- Strong analytical skills and ability to distill key information from various data sources
- Demonstrated ability to collaborate and work within cross-functional technical teams
- Experience in authoring relevant CMC sections of regulatory submissions (IND/IMPD and BLA) and served as SME in key regulatory interactions
- Possess ability to solve problems methodically; able to take initiative and act independently. Must have excellent written and oral communication skills
- Ph.D. degree in Biological Sciences or equivalent. B.S/M.S with additional years of experience.
- Senior Scientist: Ph.D. with minimum 3 years or B.S/M.S. and a minimum 7 years
- Principal Scientist: Ph.D. with minimum 5 years or B.S/M.S. and a minimum 10 years
As the leading employer in our industry in the Pacific Northwest, Seagen, Inc. 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, Inc., please visit www.seagen.com.
Seagen, Inc. 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.