Scientist, Formulation and Drug Product Sciences (FDPS) - Bothell, WA | Biospace
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Scientist, Formulation and Drug Product Sciences (FDPS)

Seattle Genetics, Inc.

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Location:
Bothell, WA
Posted Date:
6/21/2017
Position Type:
Full time
Job Code:
1972
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

Summary:

This position will focus on formulation development and characterization of Seattle Genetics' (SGEN) antibodies and antibody-drug conjugates (ADCs). The successful candidate will work closely with Process Development, Analytical Sciences, and Quality Control. The successful candidate will also perform formulation development and process characterization to support regulatory filings.

Responsibilities:

   
        
  • Develop robust liquid and lyophilized formulations for antibodies and ADCs
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  • Develop robust manufacturing processes, develop lyophilization processes, perform technology transfer to CMOs, and support drug product manufacturing
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  • Design and prepare study protocols, present study results to cross-functional groups, and generate technical reports and CMC documents required for various global regulatory submissions (e.g. IND, BLA, IMPD, CTA, etc.)
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  • Represent group as technical lead on CMC and other cross-functional teams; develop and lead group initiatives and research projects
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  • Supervise and mentor research associate(s)
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Requirements

Qualifications:

  • Ph.D. in Pharmaceutical Sciences, Biochemistry, Analytical Chemistry, or related discipline and 2+ years industrial experience
  • Demonstrated protein formulation development experience, late-stage development experience preferred
  • Expertise in structural and functional characterization of biomolecules
  • Hands-on experience with chromatographic (e.g. SEC, RP, HIC) and electrophoretic (e.g. CE, icIEF) techniques as well as other biophysical characterization techniques
  • Familiar with aseptic processing and experience in technology transfer for GMP parenteral drug product manufacturing
  • Ability to independently lead formulation development activities, cross-functional development teams, and department initiatives
  • Excellent oral and written communication skills
  • Experience with regulatory submissions
  • Supervisory and leadership experience preferred

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.