Senior Manager Quality Control Systems - Launch Pad

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 acts as a liaison between the software systems that generate and store Quality Control (QC) data and the departments across Launch Pad site that make decisions based on QC data. This position ensures alignment across departments, champions continuous improvements, and fosters relationships across all sites and departments that are stakeholders in QC data and systems for our new manufacturing site (Drug Substance, Drug Product, Testing, Labeling and Packaging) in Everett, WA.  Working closely with Manufacturing and Validation on implementation of the QC equipment and systems within the laboratory and manufacturing floor is required. 

This position manages the QC Systems used to generate GMP data (including LIMS) and QC projects for Launch Pad.  QC Software and equipment validation in combination with Part 11 Compliance is also overseen by this role. This position reports to the Head of Quality Control. 

 
Principal Responsibilities: 

  • Facilitate building and enhancing strong relationships between the QC Systems group and stakeholder groups (TOPS Data Sciences, other QC groups, Quality, IT, Facilities, and other groups within Technical Operations) within Launch Pad. 
  • Actively encourage and foster direct reports to seek out and implement process and system automations and improvements where possible. 
  • Work with SQL Server Management Studio, Crystal Reports, and other database query and reporting applications as needed to:
    • Provide routine and ad hoc QC information, metrics, and sample data/results to peers, management, and other groups / departments
    • Create and manage reports for sample labels, product release certificates of analysis (CoAs), and other reports needed by QC
  • Administer QC laboratory information management system (LIMS) with peers including but not limited to:
    • Create and manage testing templates including but not limited to batch release testing, stability testing, calculations, schemas, electronic laboratory notebook (ELN) templates, etc. 
    • Create and manage views for LIMS that integrate with other software (such as Discoverant, PowerBI, etc.)
    • Provide customer support to QC and Technical Operations for requests, questions, and issues with LIMS and integrations with other systems
    • Support LIMS software updates and upgrades by writing and revising software validation documents (specifications, user requirements, test scripts and reports), initiating change requests, and executing and reviewing test scripts
    • Train and mentor new LIMS administrators
    • Work with direct reports, QC and Quality colleagues, IT, and other stakeholders to address issues with LIMS, other software owned by QC, and processes owned by QC Systems
    • May act as subject matter expert (SME) for QC’s data integrity assessments and some processes owned by QC Systems
    • May act as administrator for other non-LIMS software owned by QC (e.g., Empower, 32 Karat, etc.)
    • May act as change champion for new systems/software from IT, HR, Quality, or other departments 

Expected Qualifications 

  • 14+ years relevant GMP/QC experience 
  • Bachelor's degree or associates degree and 2+ years in relevant field 
  • 5+ years of experience supervising/managing direct reports 
  • Ability to quickly adjust and re-prioritize current tasks based on strategy or timeline changes from sources within QC Systems, within QC, or outside of QC with little lead time or notice 
  • Excellent customer service skills, communication and collaboration skills 
  • Experience with managing data in relational databases (e.g., LIMS) and query/reporting applications 
  • Experience with software administrator and/or super user role 
  • Experience with PowerBI, Discoverant, or comparable data reporting/analysis/visualization applications 
  • Experience with equipment and software validation and Part II Compliance 
  • Familiarity with sample management and logistics 

  

Preferred Qualifications 

  • Expert with LIMS and analytical instrument software such as Empower, 32 Karat, UV-Vis ChemStation, SoftMax Pro, iCE CFR, PharmSpec 

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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