Senior/Principal Scientist BioProcess 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: 

The BioProcess Development Department at Seagen seeks a Sr. Scientist / Principal Scientist (level depending on experience), who will lead early- and or late-phase clinical programs and provide technical input to cross-functional projects and initiatives within Process Sciences, as well as lead Technology Development efforts within Purification Development.  The ideal candidate will have expertise in and a deep understanding of all common downstream unit operations, including chromatographic and filtration- based separation techniques, as well strong critical thinking skills, and an ability to design, execute, and draw conclusions from experimental studies.  This individual will author regulatory submissions and will lead product characterization studies as required to support clinical program development.  The Senior / Principal Scientist will interface cross-functionally with Product Supply and Process Sciences through participation in CMC project teams and will provide supervision and technical leadership to direct and matrixed reports within BioProcess Development.  This individual will contribute to and help foster a culture of collaboration, innovation, and scientific excellence within the organization. 
 
Principal Responsibilities: 

  • Serve on early- and/or late-stage clinical program CMC teams as purification lead, supporting product development and ensuring successful acceptance of global regulatory filings 
  • Manage process development activities and tech transfer to support internal/external manufacturing, as required 
  • May provide technical support as a Process Sciences SME for Commercial programs, as required 
  • Interact closely with cross-disciplinary project teams to advance technology development efforts in support of clinical development, including Analytical Sciences, Quality, Regulatory and other BioProcess Development groups 
  • Lead intradepartmental projects and initiatives involving other contributors 
  • Lead and perform hands-on work in the small-scale purification development laboratory working with state-of-the art instrumentation, such as TECAN and AKTA systems 
  • Provide subject-area expertise in BioProcess and CMC development, and mentor other group members in all aspects of core group work 
  • Lead viral validation studies as required to support CMC development 
  • Author high-quality regulatory submissions and technical reports; independently prepare and present experimental findings at department, project team, and senior management meetings 
  • Supervise staff in direct and matrixed reporting capacities, and provide appropriate feedback, guidance, and mentoring 

Qualifications: 

  • Expertise in and a deep understanding of all common downstream unit operations, including chromatographic and filtration- based separation techniques, such as tangential flow filtration, dead-end filtration, and all types of protein chromatography commonly used in BioProcess Development 
  • Subject area expertise in one or more areas of technical focus, such as TECAN / robocolumn separations, mechanistic modeling, viral clearance validation, etc. 
  • Demonstrated capacity to resolve complex scientific problems with appropriately designed experimentation, including practical experience in experimental approaches. 
  • An understanding of viral clearance validation in downstream bioprocess development is required 
  • An understanding of Design of Experiment (DoE) methodology, as well as experience using statistical analysis tools, such as JMP, is required 
  • Prior experience with tech transfer is required 
  • Demonstrated experience and success working in cross-functional roles, with a sophisticated understanding of CMC clinical development, beyond the Purification perspective 
  • Prior experience performing process characterization (PC) studies, process performance qualification (PPQ), and other late-stage development activities would be advantageous. 
  • Prior experience preparing regulatory filings including IND/IMPD applications, amendments, and comparability studies is required. Expertise with registrational filings (i.e. BLA) would be advantageous 
  • Scientific creativity, collaborative ability, and good written and verbal communication skills are essential 
  • Previous supervisory experience is required 

Education: 

  • PhD in Chemistry, Biochemistry, Chemical Engineering or related, with a minimum of 5+ years (Sr. Scientist) or 8+ years (Principal Scientist) relevant industry experience; or MS degree with a minimum of 11+ years (Sr. Scientist) or 14+ years (Principal Scientist) of relevant industry experience; or BS degree with a minimum of 14+ years (Sr. Scientist) or 17+ years (Principal Scientist). The hiring level will be commensurate with the combination of education and relevant experience 

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. 

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