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MSAT Principal Scientist, Drug Product Biologics - Launchpad

companySeagen
locationEverett, WA, USA
PublishedPublished: 12/8/2023
Full Time

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:

Seagen’s new cGMP manufacturing facility “project Launchpad” is being built in Everett, Washington, just North of Seattle. Launchpad will be a greenfield build encompassing end-to-end manufacturing capabilities for biologics and antibody-drug conjugates (ADCs).The Principal Scientist uses expert knowledge of scientific principles and concepts to solve complex manufacturing-related issues in creative and effective ways. They serve as technical advisors to senior management and build relationships between functional areas or external partners. They advise on patent or CMC regulatory strategies and develop approaches to resolve regulatory issues within project teams. They demonstrate technical proficiency, scientific creativity, collaboration with others, and independent thought to support and influence teams. They establish a long-term vision of skill sets for their functional area and prioritize/allocate effort in teams. They may supervise staff and would be responsible for driving the development of those employees. The Principal Scientist develops an external presence as a technical leader in the field by authoring journal articles, presenting posters at leading external scientific meetings, or as an invited speaker.

Responsibilities:

  • Leverages scientific and technical experience in initiating new projects or bringing new scientific technologies that address important business needs. Pursues new areas of process and manufacturing
  • Establishes business practices that advance manufacturing. Develops approaches that allow resolution of discrepancies and regulatory issues
  • Leads inter-departmental teams and represents department in senior management meetingsGuides commercial development efforts to comply with regulatory expectations. May defend position in front of regulatory agencies
  • Thorough understanding of ICH and Regulatory Guidance and applies knowledge to drive regulatory strategies for development and CMC documents
  • Responsible for leading drug product manufacturing technical support for internal or external manufacturing
  • Provides technical leadership for clinical or commercial stage programs, including sub-team representation
  • Provides person-in-plant manufacturing oversight
  • Provides guidance for root cause investigations of process related deviations, including CAPA design and implementation
  • Performs technical review of manufacturing related documentation
  • Identifies and initiates process and procedural changes to improve process performance and robustness
  • May oversee scientists or associates to deliver manufacturing activities or initiatives. Motivates and supports the career development and technical growth of direct reports
  • Authors technical summaries, white papers, or publications (internal or external) which support department’s policies and goals

Qualifications:

  • Strong technical experience within relevant development and/or manufacturing technologies and unit operations. Preferably experience with equipment utilized in commercial cGMP manufacturing facilities
  • Demonstrated expertise in drug product biologics manufacturing
  • Good knowledge of structured methodologies for process design, scale-up/down models, process control strategies, process validation and continuous process verification
  • The ability to work effectively in small matrix teams in a fast-paced environment with changing priorities and a high level of urgency
  • Highly motivated with the ability to work independently as well as on cross-functional and cross-site teams
  • Experience working with Contract Manufacturing Organizations
  • Strong communication skills and computer literacy

Education:

  • B.S. and 10+ years; M.S. and 8+ years Ph.D. and 5+ years


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.  

The hiring pay range for this position is $141,000 to $182,600 per year based on skills, education and experience relevant to the role.  Other components of total compensation include a competitive equity grant at the time of hire and an annual bonus.  

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