Director Formulation and Drug Delivery Pharmaceutical Sciences

Process Sciences Bothell, Washington


Description

Summary: 

This position will focus on formulation development of Seagen antibody and antibody-drug conjugate (ADC) drug products, especially related to drug product delivery. The successful candidate will work closely with Bioprocess Development, Analytical Sciences, and Quality Control. The successful candidate will lead formulation and drug product development, delivery development (intravenous, subcutaneous, intravesical) and characterization, develop talents, and support regulatory filings. 
 
Principal Responsibilities: 

  • Provide strategic oversight and leadership on product development activities including formulation and DP development, technology transfer, and process characterization 
  • Strengthen the technical capacity for drug delivery and application of delivery device 
  • Lead a high-performing team for pre-formulation, formulation, and DP process development, and continue improve in-house expertise and laboratory capacity 
  • Leading the effort in developing stable liquid and lyophilized formulations for antibodies and antibody drug conjugates (ADCs). Oversee multiple development projects including early phase and later phase programs 
  • Provide strategic contributions to department operation and product development. Support senior leaders on continuous growth of the department, such as incorporate new technologies, improve efficiency, and establish best practices 
  • Provide strategic contribution to the strategy, practice, and operations in CMC development. Lead or participate cross-functional taskforces and initiatives 
  • Review or author relevant CMC sections of regulatory submissions. Serve as SME or provide strategy guidance for key regulatory interactions 
  • Support technical transfer and manufacturing activities at fill finish CMOs. Cultivate excellent working relationship with internal and external partners to deliver successful manufacturing processes 
  • Collaborate effectively with other groups, including Purification, Conjugation, Analytical, Quality, Regulatory, Clinical, and Manufacturing and Supply Chain Management.  
  • Participate or support budgeting process 
  • Recruit, motivate and develop staff, encourage personal growth and operational excellence 

 Qualifications: 

  • M.S with 15+, or Ph.D. with 10+ years of industrial experience in Pharmaceutical Development 
  • 6 + 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, or autoinjectors 
  • Understanding of analytical and biophysical product characterization. 
  • Demonstrated early- or late-phase drug development and regulatory submission experience global submission experience preferred; combination product or device submissions is a plus 
  • Experience of combination product and device development and submission 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, 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.  

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