Manager Stability Program Management

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 Stability function is part of the Quality Control unit and is responsible for the design, governance, and operation of harmonized, compliant, and state of the art stability programs at Seagen. The Stability function and Manager ensure stability strategy is integrated into the broader program strategy. The Stability Manager is focused on managing the stability program for ADC GMP intermediates (mAb and drug linker), drug substance, drug product intermediates and drug product for clinical and commercial programs. This individual acts as stability subject matter expert for their assigned program(s) and for stability quality processes and systems. This individual may lead or support projects for stability program management or related quality continuous improvement. The qualified person has a strong knowledge of global stability requirements, including studies required to support development, commercialization, and expiry strategy.  

Principal Responsibilities 

  • Lifecycle management of the stability program for clinical and commercial products 
  • Act as representative on cross-functional quality or technical product teams to integrate stability activities with project milestones 
  • Design stability protocols aligned with program strategy and regulatory requirements and ensure stability studies executed according to protocol 
  • Interpretation of stability results to support expiry, trending, and conditions of real-world use 
  • Report stability findings and conclusions for studies including annual batch, temperature cycling, photostability, reconstitution, and comparability studies in written reports and presentation form 
  • Review, verification, disposition, and archival of stability study data for assigned programs  
  • Responsible for product stability related sections in regulatory submission, including responses to questions and post-marketing commitment support 
  • Escalates unexpected data trends, OOS events, and risks appropriately, and drives/supports resolution 
  • This position primarily interacts with analysts/associates/scientists/managers in TOPS within Seagen and/or CMO/CTL quality organizations. In addition, some interactions with partners may occur 

Required Qualifications: 

  • 12+ years relevant experience in the biotech or pharmaceutical industry  
  • BS/BA in a relevant field  
  • Prior experience with stability program management or stability testing in a commercial or development environment  
  • Experience with global stability requirements  
  • High competence in cGMPs and ICH requirements  
  • Strong scientific background and experience in the assessment of technical data and scientific information  

Preferred Qualifications: 

  • Prior knowledge and experience with the application of statistics for stability design and data evaluation  
  • Experience with CMC regulatory filings, global health authority interactions (e.g., inspections, meetings, Q&A interactions, etc.)  

 

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-KC1