Associate Director Analytical Sciences
This position is responsible for leading the analytical biochemistry group with a staff of >15 employees within the analytical sciences department. This position will be responsible for developing staff, providing technical guidance, and provide strategic oversight for analytical method development life cycle, analytical technologies, product characterization, and molecular/structural elucidation for product and process understanding. This position will interact and 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 successful candidate will coordinate resources within analytical biochemistry to accomplish such strategic objectives, drive continuous improvement, and develop long-term analytical strategies. The candidate will author/review key technical and qualification 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 as well as research team leads withing the Research Organization. .
- Lead the analytical biochemistry group within the Analytical Sciences Department, providing technical, managerial and strategic leadership to the group
- Oversee areas of analytical development including management of the analytical representatives on early, late, and commercial CMC teams, early molecule developability assessment, technology innovation, method development, transfer and lifecycle management, comparability, and product characterization
- Mentor analytical representatives to achieve CMC team objectives
- Oversee method qualification and transfer to Quality Control
- Collaborate with Research to bring new molecules into process development. Deploy resources intelligently to perform at-risk development activities prior to development decision
- 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 team work and communication amongst staff. Build a reputation for excellence both as an individual and as a team
- Establish control strategy approaches that enable fast entry to IND with sufficient product knowledge to also allow moving quickly into late stage/commercial development and product characterization
- 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
- Ph.D. degree in Biological Sciences or equivalent with a minimum of 8 years or B.S/M.S and minimum of 15 years of relevant industrial experience
- SME and extensive experience in the analytical development space. Including a solid knowledge of protein chemistry and analytical techniques
- Leadership role in taking late stage programs through product characterization
- Strong analytical skills and ability to distill key information from various data sources
- Demonstrated ability to collaborate and lead 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
- Strong management skills and have a proven track record of developing employees
- 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, Seattle Genetics 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 Seattle Genetics, please visit www.seattlegenetics.com.
Seattle Genetics 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.