Associate Director, External 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 Associate Director, External QC, is responsible to set the strategic direction for function and oversee in-process, release and stability testing performed by Contract Manufacturing Organizations (CMOs) and/or Contract Test Organizations (CTOs) for Seagen products. This position is responsible for ensuring CMO/CTO release and stability testing is performed according to cGMP requirements, Seagen quality standards, while providing visibility on CMO/CTO performance to Global Quality. Additional responsibilities may include contributing Key Performance Indicators (KPI’s) of CMO/CTO to Global Quality reports. 

Responsibilities:  

  • Provide leadership, vision, set strategic and tactical direction to the External QC Group in the cGMP environment 
  • Manages the review of Quality Agreements and contracts, ensuring alignment among CTOs when possible 
  • Manages the employee performance process and career development for the External QC team 
  • Lead selection/qualification of new CTOs, and ensuring harmonization between sites 
  • Implement/manage metrics (e.g., KPIs) to monitor key attributes, implementing corrective and preventive actions as needed 
  • Build/maintain strong collaborative relationships with CTOs, and hold them accountable to the Seagen quality standards as per the Quality Agreements 
  • Ensure CTO managers work closely with QC Leads (QCLs), keeping them informed of productive specific activities and investigations (e.g., LIRs, OOS, OOT, etc.) 
  • Develop team’s goals and milestones to meet QC targets for commercial and/or clinical development programs 
  • Build the team to achieve program goals through collaboration with internal stakeholders and external partners 
  • Recruit, retain and develop the External QC team 
  • Serve 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 stakeholders to understand strategy and future needs 
  • 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, 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 

Qualifications:  

  • Bachelor’s degree in life science in biology, biochemistry, or any related technical discipline 
  • A minimum of 10 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 (recommended 16+ years overall relevant experience) 
  • A minimum of 5 years in direct supervision of laboratory staff or project management.  
  • Experience managing QC activities for outsourced testing activities 
  • Experience playing a lead role in Health Authority (e.g., FDA & EMA inspections) 
  • Experience in conducting lab investigations on biological or small molecules 
  • This individual should have an in-depth knowledge of Antibody Drug Conjugates (ADC) or monoclonal antibody product development and test methods applied for cGMP testing.  
  • Strong QC mind-set with extensive knowledge of regulatory expectations for clinical product development 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 
  • Excellent communication skills 
  • Experience with phase appropriate cGMP development environment 

Preferred Qualifications:  

  • Hands-on QC testing experience with biologics (including ADC), aseptic products (both liquid and lyophilized forms) 
  • Demonstrated experience in successfully leading QC teams in a matrix environment to deliver strategic vision 
  • Strong project management skills and experience managing multiple projects at the same time is essential 
  • Demonstrated excellence in written and verbal communication 
  • Demonstrated ability to work cross-functionally and develop strong business partner relationships in a matrix-environment across organizations 
  • 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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