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Senior Quality Control Analyst

companySeagen
locationBothell, WA, USA
PublishedPublished: 12/8/2023
Full Time

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:

Performs routine and non-routine testing with expert proficiency and general QC laboratory work for release of Direct Raw Materials to support Seagen’s clinical development and/or commercial products in a GMP testing environment.

Principal Responsibilities:

  • Applying the principles of good manufacturing practices (GMP) on a daily basis
  • Performing sample testing for raw material release testing
  • Analyzing and compiling data and preparation of reports
  • Reviewing assays/data for compliance to specifications and reports abnormalities
  • May require lifting/moving heavy objects
  • Support Release of raw material lots, CoA generation and approval
  • Creating and revising standard operating procedures (SOP’s, Specifications, and Test Methods) and other documents as needed
  • Identifying and leading continuous improvement projects
  • Supporting special projects for analytical problem solving
  • Participating in the qualification and validation of test methods
  • Troubleshooting laboratory or system anomalies
  • Authoring and owning deviations, CAPAs and Change Controls
  • Method or system development and/or optimization
  • Training other personnel
  • Serving as SME for Test Methods or other areas of expertise
  • Providing oversight for programs, specific to job function
  • Representing QC in cross-functional teams
  • Weekend, Holiday, overtime, and off-hour work may be required as needed to support manufacturing

Expected Qualifications:

  • Associates degree in a relevant field with 2 years of experience or a Bachelor's degree in a relevant field (in addition to 8+ years of relevant experience)
  • Broad experience with Microsoft Office products
  • Be highly organized with an attention to detail
  • Strong data interpretation/analytical skills
  • Strong troubleshooting skills
  • Strong knowledge of GMP compliance
  • Strong technical writing and communication skills
  • Experienced in lab equipment (pH meters, balances, pipettes, HPLC's/plate readers, automated titrators, spectrophotometric instrumentation, etc.)
  • Experience authoring or revising Standard Operating Procedures
  • Familiarity with Change Control
  • Participation in Laboratory Investigations
  • Ability to keep order of multiple projects/tasks

Preferred Qualifications

  • 4+ years of experience working in a GMP laboratory
  • Participation in Laboratory or Out of Specification Investigations
  • Experience or working knowledge of compendial methods/monographs as it applies to raw material testing

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. 

The hiring pay range for this position is $94,000 - $121,000 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire and an annual bonus.

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. 

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