Do you want the opportunity to provide scientific and technical leadership in a growing function within Seattle Genetics? Through strategic thinking and strong leadership, you will be able to directly contribute to establishing the framework that will support all current and future drug product development activities for small molecule programs. This is an excellent opportunity to apply your experiential formulation and process development knowledge to drive strategic direction in a creative and highly collaborative environment. We're looking for a leader that will own initiatives, have a focus on excellence, and influence the larger organization. Is this you?
Seattle Genetics is seeking a highly motivated senior/principal scientist in formulation and drug product sciences (FDPS) with experience in development and manufacture of small molecule solid oral dosage forms. The position requires an in-depth understanding of chemistry manufacturing and controls (CMC) development, cGMPs, and experience with supporting regulatory submissions. The successful candidate will work closely with Quality Control, Process Chemistry, and Product Supply groups to support the development of formulations and manufacturing processes for small molecule programs.
Independently design, execute, and interpret formulation and process optimization studies. Provide clear data interpretation and recommendations
Coordinate and oversee development activities, technical transfer, and/or cGMP manufacturing at external vendors
Present study results internally/externally. Support authoring of CMC sections for regulatory filings
Troubleshoot and resolve complex manufacturing process challenges associated with typical solid oral dosage unit operations
Supervise and/or mentor junior staff
Lead technical initiatives, special FDPS research projects, and/or project working group
Principal scientist may serve as CMC project team lead
The principal scientist will provide strategic direction to grow the small molecule FDPS capabilities and build upon the function's value stream
M.S. or Ph.D. in Pharmaceutical Sciences, Chemistry, Materials Science, or related discipline
M.S. and 10+, or Ph.D. with 3+ years of industrial experience; M.S. and 13+, or Ph.D. with 6+ years for Principal Scientist
3+ years supervisory or leadership experience for Principal Scientist
Proven track record in formulation and process development of solid oral dosage forms, scale-up, and technical transfer. Working knowledge of powder blending, wet/dry granulation, tablet compression, and film-coating unit operations required
Experience in pediatric formulation development and/or controlled/modified release required
Demonstrated ability to provide contract development and manufacturing organization (CDMO) oversight and drive results through external vendors
Prior involvement in authoring regulatory submissions
Experience defining process development strategies and authoring CMC content in an NDA required for Principal Scientist
Excellent oral and written communication skills
Knowledge of spray drying, solid-state characterization (differential scanning calorimetry, thermogravimetric analysis, particle size, etc.), and/or analytical release testing method development a plus
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.