Associate Scientific Director - Mass Spectrometry Core Leader
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!
This position is responsible for leading the core mass spectrometry (MS) function with a staff of 8 employees within the Analytical Sciences group. This position will be responsible for developing staff, providing technical guidance, and providing strategic oversight for analytical mass spec technologies, method development, product characterization, and molecular/structural elucidation for product and process understanding. This position will interact and partner with Analytical Sciences leadership to shape the MS-based component of analytical CMC strategies such as comparability, CQA control strategy, and regulatory submissions, with the end goal of developing and registering biologics products worldwide. The candidate may 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 within the Analytical Development, Bioprocess and Pharmaceutical Sciences and Data Sciences departments.
- Lead the core mass spectrometry group within the Analytical Sciences group, providing technical, managerial and strategic leadership to the group
- Mentor MS core group members on intra- and inter-departmental interactions and collaborations needed to facilitate first-in-human and late phase drug-development and biologics registration
- Identify key-strategic areas of technology development that, if implemented, position the MS core group to meet the internal demand for MS core support in a scalable manner
- Review MS data and technical reports associated with regulatory filings and interdepartmental process development activities
- Manage MS core group meetings with the aim of establishing a common vision, building team inclusivity and a sense of shared responsibility, mentoring junior staff and facilitating group review and discussion of MS data
- Oversee relevant CMC sections of regulatory submissions and serve as a subject matter expert in regulatory interactions as needed
- Drive the implementation of new MS technologies to support company’s business objectives
- Collaborate with partners in the Analytical Development, Bioprocess, Pharmaceutical Sciences and Data Sciences departments to advance our understanding of the process to product quality relationships
- Cultivate and maintain external presence by creating opportunities for collaborations to advance industry practices in drug development and manufacturing, including regulatory strategy
- Guide career development of MS core group staff and build leadership capability within the group
- Encourage personal growth. Foster good team-work and communication amongst staff. Build a reputation for excellence both as an individual and as a team
- Collaborate effectively with departments within and outside of TOPS organization
- Ph.D. degree in Biological Sciences or equivalent with a minimum of 8 years or B.S/M.S and minimum of 17 years of relevant industrial experience
- Prior experience managing and guiding the careers of scientific staff
- Extensive experience with common MS instrument platforms and MS data analysis software
- SME and extensive experience in the use of mass spectrometry for biotherapeutic protein characterization in a research and development organization
- Deep understanding of scope and extent of MS characterization activities that are done to support late-stage programs through product characterization to support registration
- Strong analytical skills and ability to distill key information from various data sources
- Demonstrated ability to link molecular product quality attributes to analytical assays used for product quality release and stability
- Extensive prior experience linking changes in molecular product quality attributes to process optimization carried out across a variety of functional areas including cell-line development, cell culture, purification, conjugation etc.
- Demonstrated ability to collaborate and lead cross-functional technical teams
- Experience in authoring relevant CMC sections of regulatory submissions (IND/IMPD and BLA)
- Possess ability to solve problems methodically; able to take initiative and act independently. Must have excellent written and oral communication 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.
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.