Senior/Principal Scientist/Engineer, Formulation Development with Combination Product Development

Process Sciences Bothell, Washington


Description

Do you want the opportunity to provide scientific and technical leadership in a growing function within Seagen?  Through strategic thinking and strong leadership, you will be able to directly contribute to expanding the capabilities that will support all current and future combination product and device development of Seagen’s antibodies and antibody-drug conjugates.  This is an excellent opportunity to apply your formulation development, process development, combination product development, and device development knowledge to drive strategic direction in a creative and highly collaborative environment.  We are looking for a leader that will own initiatives, have a focus on scientific excellence, and influence the larger organization. Is this you?

 

As a successful senior/principal scientist/engineer, you will enhance the long-term growth of Seagen’s 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, drug product, and combination 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.  Experience in late-stage combination product development and/or device development is preferred.

Responsibilities:

  • Development of robust liquid and lyophilized products for antibodies and antibody-drug conjugates (ADCs)
  • Design and execute formulation development studies, stability studies, combination product development studies, and shipping/handling studies for injectable products, utilizing appropriate analytical tools
  • Evaluate and define the optimal primary storage container and delivery device for parenteral drug products
  • Stability evaluation of material for use in toxicology and clinical studies
  • Conduct technology transfer and scale-up of drug product manufacturing process and manage applicable device manufacturing processes
  • Conduct and manage combination product development studies, including functionality and human factors testing
  • 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), scientist(s), and/or engineer(s)

Qualifications:

  • S., M.S., or Ph.D. in Pharmaceutical Sciences, Biological Sciences, Biomedical or Chemical Engineering, Mechanical Engineering, Material Science, or a related discipline
  • D. with 5+ years of industry experience; B.S. or M.S. with commensurate amount of industry 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 combination products for injectable products such as prefilled syringes, injection pens, autoinjectors, or patch pumps
  • Demonstrated early- or late-phase drug development and regulatory submission experience; global submission experience preferred; combination product or device submissions is a plus
  • Hands-on experience and excellent understanding of combination product and device development preferred
  • Hands-on experience and excellent understanding of analytical and biophysical product characterization preferred
  • Familiar with aseptic processing and experience in technology transfer for parenteral drug product 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.

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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