Senior/Principal Scientist, Formulation and Drug Product Sciences
The Senior/Principal Scientist uses expert knowledge of scientific principles and concepts to serve as the single departmental point of contact, and demonstrates technical proficiency, scientific creativity, collaboration with others, and independent thought. They work on drug development problems of diverse scope by leveraging data analysis to identify innovative and practical solutions. They identify and champion new ideas and technologies that enhance business processes within formulation and drug product sciences. They develop an external presence as a technical leader in the field by authoring journal articles, presenting posters at leading external scientific meetings, or as an invited speaker.
- Applies practical and theoretical expertise of the relevant area of science, process and assay development, and manufacturing.
- Leads formulation assessment for early and/or late-stage antibody and antibody-drug conjugate programs independently. May develop more complex formulations.
- Independently designs and executes studies used to support formulation development, including evaluations of stability, clinical in-use, and forced degradation characterization.
- Leverages literature, ICH/Regulatory guidance, and practical experience to perform their work and influence CMC strategies.
- Recommends and implements new technology that advances knowledge and productivity within department.
- Motivates and supports the career development and technical growth of direct reports. Regularly meets with, sets clear goals and expectations, and provides timely feedback to direct reports.
- Authors and reviews technical reports, manufacturing documents, regulatory submissions and publications.
- Presents at department, project team, and sr. management meetings. May present externally at scientific conferences.
- Additionally, the Principal Scientist serves as a technical advisor to senior management on risks to project. 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.
- At least 2 years supervisory or leadership experience
- At least 50% 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
- Proven expertise in structural and functional characterization of biomolecules or DP process development
- Hands-on experience and excellent understanding of analytical and biophysical protein characterization including HPLC, CE, IEF, CEX, SDS-PAGE, AUC, DSC, CD, FTIR, Fluorescence
- Proven ability to lead formulation development teams
- Excellent oral and written communication skills, ability to lead cross-functional development teams, and capability to provide strategic contributions.
- Principal scientist level requires broad subject matter expertise in multiple technical areas of formulation or DP process development, working knowledge of both. Extensive experience required in supporting regulatory submissions and a thorough understanding of ICH and Regulatory Guidance.
- M.S. or Ph.D. in Pharmaceutical Sciences, Biological Sciences, Material Science, Biomedical or Chemical Engineering, or a related discipline
- Scientist level – M.S. with 11+ years or Ph.D. with 3+ years of industrial experience
- Principal Scientist level – M.S. with 14+ years or Ph.D. with 5+ 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.