Seagen

Quality Control Analyst II/III Critical Reagents

Technical Operations & Process Sciences - Bothell, Washington

Description

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

Maintains and ensures continuity of supply of critical reagents to support QC laboratories across internal and external sites. Performs qualification testing with intermediate proficiency and general QC laboratory work. May provide support for release and/or stability testing of 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 critical reagent qualification testing
• Reviewing and evaluating assays/data
• Troubleshooting method or material anomalies
• Facilitating and coordinating the acquisition, transfer, shipment, or disposal of critical reagents
• Maintaining inventory of critical reagents in QC to support routine testing
• Monitoring critical reagent inventory internally and across external sites
• Supporting internal and external organizations to ensure supply continuity
• Identifying and leading continuous improvement projects
• Maintain training to current standards and procedures on all assigned curriculums
• Fully comply with company health and safety procedures and practices

Additional Responsibilities for QC Analyst III:

• Designing critical reagent qualification protocols/plans and experiment outlines
• Authoring and revising standard operating procedures (SOP’s), technical reports and other documents as needed for change or improvement
• Authoring and owning deviations, CAPAs and Change Controls
• Serving as SME for Critical Reagents or other areas of expertise
• Training other personnel

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 2+ years of relevant experience)
• Broad experience with Microsoft Office products
• Highly organized with an attention to detail
• Familiarity with plate-based potency assays such as ELISAs or bioassays
• Proficiency in running plate-based potency assays
• Proficiency in sterile technique
• Experience with lab equipment (pH meters, balances, pipettes, plate readers, plate washers, cell counting systems, freezers, incubators, BSC, etc.)
• Able to handle multiple tasks in an organized and time-efficient manner
• Strong data interpretation, critical thinking, and problem-solving skills
• Strong technical writing and communication skills
• Ability to work well in a team environment and interacting with various departments of the company

Additional Qualifications for QC Analyst III:

• Associates degree in a relevant field with 2 years of experience or a Bachelor's degree in a relevant field (in addition to 5+ years of relevant experience)
• Strong understanding of plate-based potency assays
• Method troubleshooting skills and strong scientific understanding of protein molecules
• Experience authoring or revising Standard Operating Procedures and Technical Reports
• Participation in Laboratory Investigations

Preferred Qualifications:

• 2+ years of experience working in a GMP Laboratory

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, 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: 05/06/2022