Scientist/Senior Scientist Formulation and Drug Product Sciences (FDPS)

Process Sciences Bothell, Washington


Description

Do you want the opportunity to provide scientific and technical leadership in a critical function within Seagen? As a member of the pharmaceutical sciences group, you will be able to utilize your strong scientific skills to develop robust formulations and drug product processes for world-class antibodies and ADC cancer therapies. Working cross functionally to ensure high quality products are delivered to patients is a key requirement for the position. We’re looking for someone who is enthusiastic, knowledgeable, and can step in right away to contribute as a team player to project development. Is this you? 

Summary:

The primary functions of this position will be to serve as the formulation and drug product development lead for early and/or late stage clinical programs, lead technology development efforts within the formulation and drug product sciences functional area, and provide technical support to cross-functional projects within process sciences. This individual will oversee development of formulation, drug product process development and technology transfer, clinical administration, and process characterization for Seagen' antibodies and antibody-drug conjugates (ADCs) to support regulatory filings. The successful candidate will interface cross-functionally on CMC project teams. In particular, the candidate will work closely with individuals from Process Development, Analytical Sciences, Quality Control groups. This individual will contribute to and help foster a culture of collaboration, innovation, and scientific excellence within the pharmaceutical sciences department.

 

Responsibilities:

  • Develop robust liquid and lyophilized formulations for antibodies and ADCs
  • Design and execute formulation development studies to support liquid and lyophilized formulation development; conduct stability and clinical in-use studies utilizing appropriate analytical tools; conduct forced degradation studies to characterize molecule degradation pathways
  • Develop robust manufacturing processes, develop lyophilization processes, perform technology transfer to CMOs, and support drug product manufacturing
  • Design and prepare study protocols, present study results to cross-functional groups, and author technical reports and CMC documents required for global regulatory submissions (e.g. IND, IMPD, BLA, MAA etc.)
  • Represent group as the formulation and drug product lead on CMC and other cross-functional teams; develop and lead group initiatives and research projects
  • Supervise and mentor research associate(s)

 

Qualifications:

  • Scientist: Ph.D. in Biochemistry, Biological Sciences, Chemical Engineering, Pharmaceutical Sciences or related discipline with 0-3 years of post-doctoral or relevant industry experience or B.S. with 10+ years or M.S. with 8+ years of relevant industrial experience
  • Senior Scientist: Ph.D. in Biochemistry, Biological Sciences, Chemical Engineering, Pharmaceutical Sciences or related discipline with 3+ years of post-doctoral or relevant industry experience or B.S. with 14+ years or M.S. with 11+ years of relevant industrial experience
  • Strong scientific acumen with ability to solve complex problems through thoughtfully designed experiments and analysis
  • Expertise in structural and functional characterization of biomolecules
  • Hands-on experience with chromatographic (e.g. SEC, IEX, RP, HIC), electrophoretic (e.g. CE, icIEF), and biophysical characterization techniques
  • Ability to independently lead formulation development activities, cross-functional development teams, and department initiatives
  • Demonstrated scientific creativity, ability to work independently and collaboratively, and good written and verbal communication skills
  • Experience with protein formulation, aseptic processing and technology transfer for GMP parenteral drug product manufacturing preferred
  • Experience preparing regulatory filings preferred
  • Supervisory and leadership experience preferred
  • Experience with high-throughput sample preparation, testing, and strategy a plus


As the leading employer in our industry in the Pacific Northwest, Seagen 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, please visit www.seagen.com.

Seagen 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.

#LI-DD1