Quality Control Manager Lab Operations

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: 

This position is responsible for overseeing the day-to-day operations of the QC Testing Lab at Seagen’s Canyon Park facility. This includes managing testing scheduling and assignments per all applicable SOPs in a GMP environment to support release and stability testing of Seagen’s clinical development and commercial products considering analyst training, Out of Office requests, and other lab responsibilities and projects. This requires close monitoring of testing volume by overseeing sample management activities including sample receipt and logging, as well as prioritization of testing activities. Additional oversight of lab operations such as weekly solution preparation and reference pulls for scheduled assays, and oversight of critical systems such as LIMS for sample and assay tracking, and TrainingWire for analyst training and SOP compliance is also required.   

Principal Responsibilities: 

  • Managing personnel and Lab Operations Subunit by overseeing operations, training, goal setting and career development 
  • Making decisions around complex issues associated with procedures and sub-function/area of expertise that may impact key program and/or inter-department processes 
  • Applying the principles of good manufacturing practices (GMP) on a daily basis 
  • Schedule all sample testing for the CP QC Testing group according to applicable SOPs 
  • Oversee testing assignments for all analysts within the CP QC Testing group 
  • Coordinate testing to ensure appropriate testing volume, prioritization, and distribution of workload among analysts considering training, Out of Office requests and other projects 
  • Oversee sample management activities, including sample receipt, shipping, storage, and logging 
  • Coordinate with sample management analysts to address sample shipping delays or other issues 
  • Coordinate sample testing around sample arrival and receipt and align with other in-house stability testing 
  • Oversee administration of critical systems such as LIMS and TrainingWire 
  • Oversee preparation of laboratory solutions following instructions in SOPs 
  • Oversee ordering of laboratory reagents, chemicals, and other consumables 
  • Oversee routine maintenance on laboratory equipment to ensure smooth operation 
  • Fully comply with company health and safety procedures and practices 

Required Qualifications: 

  • Associates degree in a relevant field with 2 years of experience or a Bachelor's degree in a relevant field (in addition to 12+ years of relevant experience) 
  • Demonstration of leadership within a GMP laboratory environment 
  • Possess strong data interpretation, method troubleshooting, skills and sounds scientific judgement 
  • Strong time management skills with attention to detail and desire to achieve team and individual goals 
  • Excellent communication skills 

Preferred Qualifications: 

  • 2+ years managing lab scheduling  
  • 3-5 years of cGMP related laboratory experience in the biopharmaceutical industry 
  • Experience with GMP lab operations and coordination of testing 
  • Experience with sample management (handling and receipt of samples and entry into LIMS system) 
  • Experience with LIMS and other computer-based compliance systems 
  • Experience overseeing day to day lab operations including solution preparation, supply ordering and routine equipment maintenance 
  • Proficient in Microsoft Office applications 

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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