Associate Director, External Process Development, Chemical Process and Analytical Development

Technical Operations & Process Sciences Bothell, United States


Description

Position at Seagen

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us! 

Summary: 

As a member of the Chemical Process and Analytical (CPAD) organization at Seagen, the Head of External Process Development is responsible for leadership of chemical and analytical development activities at contract development and manufacturing organizations (CDMOs) in collaboration with CPAD process development teams to support development and supply of pre-clinical and clinical drug linkers, new chemical entities and critical raw materials.  This position collaborates with internal stakeholders in Technical Development, MSAT, and Quality to drive alignment on external development strategies and tactics, based on industry best practices and phase-appropriate regulatory expectations.  

 

Principal Responsibilities: 

Business and Documentation 

  • Coordinate, generate and manage RFPs to CDMOs, incorporating technical requirements and details (process development and analytical development) from internal Seagen knowledge 
  • Coordinate contract negotiations and draft contracts (MSA, QTA) using best practices, to maximize ownership of – and visibility into – external development activities, collaborating with internal stakeholders (Legal, Quality, etc.) 
  • Manage the financial oversight of external development activities including invoice approvals and accruals 
  • Review and approve development reports generated at CDMOs, ensuring conformance with Seagen standards 
  • Participate in developing the GMP strategy for NCEs through development to commercialization 
  • Manage information sharing between CDMOs and CPAD project teams 
  • Develop a KPI-based strategy for managing and selecting CDMOs 
  • Partner closely with peers in Legal, Discovery Chemistry and Process Development to develop and implement strategies to protect intellectual property 

CDMO Oversight: 

  • Drive and participate in the assessment and selection of CDMOs for phase-appropriate external manufacturing of pre-clinical and clinical drug linkers, new chemical entities and critical raw materials 
  • Serve as primary point of contact from CPAD to manage technical and business interactions with CDMO sites that would ensure timely delivery of product(s) that meet mutually agreed-upon acceptance criteria, and facilitate future tech transfer for GMP manufacturing 
  • Ability to travel up to 30% to support oversight of external development activities, to interface with global Seagen colleagues and to support CPAD person-in-plant as needed during development and Phase 1 campaigns  

Qualifications: 

  • PhD in chemistry with a minimum of 7 years industry experience in internal and external process development and manufacturing in a pharmaceutical or biopharmaceutical environment, or M.Sc. with a minimum of 10 years of relevant experience 
  • Experience with both early and late phase process development, commercialization, and/or lifecycle management for approved NCEs 
  • Excellent hands-on understanding of organic chemistry on practical and mechanistic levels; solid understanding of routine analytical methods (HPLC, NMR, MS) 
  • Experience with drafting regulatory submissions 
  • Ability to assimilate, filter, and assemble technical information from a variety of sources to glean an understanding of assigned projects 
  • Clear, cohesive, and concise communication in verbal and written form 
  • Soft skills needed to influence, without direct authority, internal and external activities 

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.  

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law. 

#LI-KP1