Quality Control Analyst II

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!

Position Summary:

Performs daily sample management operations in support of release and/or stability testing of Seagen’s clinical development and/or commercial products in a cGMP compliant QC laboratory. Works closely with Routine QC Testing groups to ensure samples are available for QC Testing (received from or sent to the correct internal and external locations) and ensure complete chain of custody is maintained in accordance with standard operating procedures (SOPs). Work cross-functionally with other groups, such as Supply Chain Quality and QC Systems, to ensure continual sample management support.

Principal Responsibilities:

• Applying the principles of good manufacturing practices (GMP) on a daily basis
• Perform routine sample management activities, including sterile sample aliquoting and proper storage and disposal of samples
• Perform sample receipt and prepare outgoing shipments
• Perform sample checks and sample pulls
• Coordinate with external contract testing laboratories for sample submission and testing
• Complete and review chain of custody documentation, temperature data, and Laboratory Information Management System (LIMS) entries
• Archive chain of custody documents and other QC documentation as needed
• Perform periodic inventory of product samples and product reference materials
• Perform routine maintenance on sample management laboratory equipment, such as cleaning BSCs, refrigerators, and freezers
• Coordinate with Facilities for scheduling maintenance and repairs for sample management laboratory equipment
• Maintain communication and interaction with Shipping & Receiving and Global Logistics to organize and track delivery and shipment of samples
• Author and own deviations and change controls as needed
• Create and revise standard operating procedures (SOP’s), work instructions, and other documents as needed
• Create routine/basic testing templates in LIMS and may support LIMS team in validation of software updates and upgrades
• May assist with logging batches and setting up stability studies in LIMS
• Maintain close communication and interaction with QC Lab Supervisors and Managers to ensure on-time distribution of samples
• Establish close communication and interaction with QC Project Leads to ensure on-time distribution of samples
• Begin to review stability protocols
• Begin to take on additional roles such as Sample Management Trainer, Sample Management Subject Matter Expert for audits/inspections, or LIMS Administrator
• Trouble shoot issues with guidance
• Identify and/or participate in Lab Ops continuous improvement projects as appropriate
• Maintain training to current standards on all assigned curriculums
• Fully comply with company health and safety procedures and practices

Expected Qualifications:

• AA degree or in progress towards a Bachelor’s degree with at least 1-2 years of cGMP related laboratory experience in the biopharmaceutical industry
• Broad experience with Microsoft Office products (Excel, Outlook, etc.)
• Highly organized with an attention to detail
• Ability to keep order of multiple projects/tasks

Preferred Qualifications:

• 2-3 years of cGMP related laboratory experience in the biopharmaceutical industry
• Knowledge of biological and/or chemical handling
• Experience with a LIMS or other sample/inventory management system
• 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.

The hiring pay range for this position is $70,000 to $90,000 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 (with additional annual grants, and grants upon promotion when applicable), 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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