Seagen

Quality Control Analyst III

Technical Operations & Process Sciences - Bothell, United States

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 Seagen Quality Control (QC) Canyon Park Testing team is dedicated to supporting the release and stability testing of both our commercial and clinical stage programs. This position is responsible for performing the routine and non-routine testing and review with advanced proficiency and general QC laboratory work for the in-process support, release and/or stability of Seattle Genetics’ clinical development and/or commercial products in a GMP testing environment.

Principal Responsibilities:

• Routine performance and review of plate-based assays such as cytotoxicity bioassay, AlphaLISA, Binding ELISA and Cell Signaling Bioassay
• Author and own deviations, CAPA and Change Controls
• Revise and/or author standard operating procedures
• Participate in qualification and validation of test methods
• Work closely within the QC organization as well as on a select number of cross-functional teams to ensure successful completion of group objectives
• Work with our LIMS system to support the QC testing group
• Apply the principles of good manufacturing practices (GMP) on a daily basis
• Identify and participate in continuous improvement projects
• Participate in troubleshooting and laboratory investigations
• Serve as SME for Test Methods or other areas of expertise

Required Qualifications:

• BS/BA or AA with 2+ years in relevant field (in addition to years of experience listed below)
• 6+ years of experience in pharmaceutical/biopharmaceutical industry
• 3+ years of experience working in a GMP laboratory
• Strong technical skills and in-depth understanding of plate-based assays and cell culture
• Experience in GMP data review
• Highly organized with an attention to detail
• Strong knowledge of GMP compliance
• Strong technical writing and communication skills
• Proficient with Microsoft Applications (Word, Excel, Outlook, SharePoint, etc.)
• Strong trouble troubleshooting skills
• Strong understanding of the listed equipment
• Strong data interpretation/analytical skills
• Experience authoring or revising Standard Operating Procedures

Preferred Qualifications:

• Participation in regulatory inspections
• Experience with a laboratory information management system (LIMS)
• Proficient with SoftMax Pro software

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.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 07/15/2022