Director, Commercial Quality Control

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 Director, Commercial Quality Control (QC), is responsible for setting strategic direction for functional unit to successfully support established commercial products. This position is responsible for managing delivery of QC deliverables in support of commercial products, oversight of QC testing strategy development and QC activities to fulfill control strategies, such as method transfer, method validation, establishing international or regional testing (in country testing) product reference certification, and implementation to support cGMP manufacturing, supporting regulatory filings and interactions with health authorities and pharmacopoeias. 

 

Principal Responsibilities:  

  • Provide leadership, vision, set strategic and tactical direction to the Commercial QC Group  
  • Manages the employee performance process and career development for the team  
  • Recruit, retain and develop QC staff to support all established commercial programs  
  • serves as a leader and member in Global QC Leadership Team  
  • Sustain employee engagement by creating a culture of excellence and an environment in which individuals and teams can excel and continuously improve  
  • Develop and maintain strong and effective relationships and trust with key internal/external stakeholders to understand strategy and future needs  
  • Lead team and provide oversight for commercial product investigations and reports in response to OOS/OOE/OOT  
  • Oversee the authoring and/or review assigned CMC sections for new and amended license applications (BLA/NDA/MAA)   
  • Make decisions around complex issues associated with sub-function/area of expertise that may impact key program and/or inter-department processes  
  • Collaborate with Global Quality, development functions (i.e. Analytical Sciences, Pharmaceutical Sciences, Supply Chain, etc.)  
  • Define and manage expense budget planning and project resourcing schedules Influencing the external scientific/regulatory community through participation in external activities and conferences    

Required Qualifications: 

  • Bachelor’s degree in life science in chemistry, biology, biochemistry, or any related technical discipline
  • A minimum of 15 years relevant experience in pharmaceutical/biological drug product development, analytical chemistry and/or quality control in a regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required (preferred 18+ years overall relevant experience. In addition to a minimum of 7 years in direct supervision of staff in a cGMP environment.  
  • Experience in leading inspections and interacting with health authorities  
  • The ideal candidate for this position will have demonstrated in-depth experience of managing QC functions associated with the cGMP production and control strategies of biologic and small molecule products in commercial settings  
  • This individual should have an in-depth knowledge of Antibody Drug Conjugates (ADC) or monoclonal antibody product development and/or small molecule test methods applied for cGMP testing  
  • Experience in conducting lab / OOS /OOT investigations on biological and/or small molecules  
  • Hands-on experience with managing method transfer/validation, product reference selection, product specification setting and implementation, stability study design biological and/or small molecules  
  • Strong Quality Control mind-set with extensive knowledge of regulatory expectations for commercial products and experience of cGMP’s  
  • Strong planning and organization skills, ability to establish and manage multiple competing priorities and proceed with objectives with minimal supervision  
  • Highly collaborative with outstanding relationship building skills  
  • Adept at leading people, mentoring, and developing other leaders within the group  
  • Demonstrated excellence in written and verbal communication  
  • Demonstrated ability to work cross-functionally and develop/maintain strong business partner relationships in a matrix-environment across organizations  
  • Strong project management skills and experience managing multiple projects at the same time is essential  

Preferred Qualifications: 

  • Hands-on QC testing experience with biologics (including ADC), aseptic products (both liquid and lyophilized forms), and/or small molecules   
  • Demonstrated experience in successfully leading QC teams in a matrix environment to deliver strategic vision  
  • Ability to manage and lead in a fast pace and high change environment  
  • Strong technical writing skills 

 

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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