| Seattle Genetics
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.
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Process Sciences . Bothell, Washington
Description
As a successful senior/principal scientist, you will enhance the long-term growth of Seattle Genetics' drug product development organization through innovation, collaboration, and scientific excellence, increasing our capabilities and improving operational efficiency to deliver transformative cancer therapies. You will be a leader in injectable formulation and drug product development working closely with Process Sciences, Analytical Sciences, Manufacturing, Regulatory Affairs, and Quality. Key responsibilities include providing product and process characterization results to regulatory filings and providing technical leadership to direct and matrixed reports. Expertise in drug delivery and device development is preferred. Responsibilities: - Development of robust liquid and lyophilized products for antibodies and ADCs
- Design and execute formulation development studies, stability studies, and shipping/handling studies for injectable products, utilizing appropriate analytical tools
- Evaluate and define the optimal storage and delivery device for parenteral drug products
- Evaluate drug delivery performance and conduct device functionality and human factors 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 drug product and device manufacturing
- Lead the development work and present the results and conclusions to internal and external stakeholders
- Identify and lead initiatives to increase capabilities, enhance process efficiency, or improve cross-functional operations
- Generate technical reports and prepare CMC documents for global regulatory submissions (e.g. IND, IMPD, BLA, NDA, MAA, etc.)
- Supervise, coach and mentor research associate(s) and/or scientist(s)
Qualifications: - S. or Ph.D. in Pharmaceutical Sciences, Biological Sciences, Material Science, Biomedical or Chemical Engineering, or a related discipline
- S. and 7+ years or Ph.D. with 5+ years of industrial experience
- 5+ years supervisory or leadership experience
- Experience in developing products for intravenous, subcutaneous, intramuscular, intravesical, or other parenteral routes of administration and/or experience in developing devices for injectable products such as vials, prefilled syringes, injection pens, autoinjectors, or patch pumps
- Demonstrated late-phase regulatory submission experience
- Extensive experience in support of global regulatory submissions with experience in device and combo products submissions a plus
- Hands-on experience and excellent understanding of analytical and biophysical product characterization preferred
- Hands-on experience and excellent understanding of device development and combination product development preferred
- Familiar with aseptic processing, and experience in technology transfer for parenteral drug product and/or device manufacturing
- Excellent oral and written communication skills, ability to lead cross-functional development teams, and capability to provide strategic contributions
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.
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PI121547053
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