This position will focus on injectable formulation and drug product development for Seattle Genetics' (SGEN) antibodies and antibody-drug conjugates (ADCs). The expertise in drug delivery and device is mostly preferred. The successful candidate will work closely with Process Development, Analytical Sciences, and Quality Control. The successful candidate will also provide product and process characterization to support regulatory filings.
Development of robust liquid and lyophilized products for antibodies and ADCs
Design and execute formulation development for injectable products, conduct stability studies, and shipping/handling studies utilizing appropriate analytical tools
Evaluate and define the optimal storage and delivery device for parenteral drug product and conduct functionality testing
Stability evaluation of material for use in toxicology and clinical studies
Conduct technology transfer and scale-up of drug product manufacturing process and support manufacturing
Lead the development work and present the results to internal or external stakeholders
Generate technical reports and draft CMC documents for global regulatory submissions (IND, IMPD, BLA, NDA, MAA, etc)
Supervise and mentor research associate(s) and/or scientist
M.S. or Ph.D. in Pharmaceutical Sciences, Biomedical engineering, Engineering, Material science and Engineering, Biological Sciences or related discipline
M.S and 10+, or Ph.D with 7+ years of industrial experience
5 + years supervisory or leadership experience
Demonstrated injectable formulation development experience including some late phase/regulatory submission experience
Proven expertise in devices and delivery systems for injectable products, such as vial, prefilled syringes, injection pens, injection pumps, and others
Experience in developing product for intravenous, subcutaneous, intramuscular, and/or intravesical delivery
Hands-on experience and excellent understanding of analytical and biophysical product/device characterization
Familiar with aseptic processing, and experience in technology transfer for parenteral drug product manufacturing
Extensive experience in support regulatory submission, experience in device and combo product submission is a plus
Excellent oral and written communication skills
Ability to lead cross-functional development teams
Experience in late phase development and manufacturing
Capability to provide strategic contribution
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.