Seagen

Manager Quality Control Sample Management - Launch Pad

Technical Operations & Process Sciences - Bothell, United States

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:

Seagen’s new cGMP manufacturing facility “project Launch Pad” is being built in Everett, Washington, just North of Seattle. Launch Pad will be a greenfield build encompassing end-to-end manufacturing capabilities for biologics and antibody-drug conjugates (ADCs).

The Manager of QC Sample Management will lead a team of Scientist and Analyst level staff ensuring that raw material, in-process, and release samples are received, stored, tested, and disposed in accordance with GMP and Seagen requirements. This position is also responsible for managing outsourced testing, control of reference standards and critical reagents, and maintaining a GMP chain of custody for incoming and outgoing shipments.

The Manager of QC Sample Management will work closely with QC test labs, Manufacturing, MSAT, and other internal customers to ensure the seamless movement of GMP materials within and between sites. This position will be a critical member of the site QC leadership team and will act as subject matter expert on chain of custody, LIMS, inventory management, and outsourced testing.

This position reports to the Head of Quality Control – Launch Pad.

Principal Responsibilities:

• Develop and implement GMP chain of custody and inventory management processes for a new biologic drug substance and drug product manufacturing facility
• Work collaboratively with Manufacturing and QC test labs to ensure that all required test samples are received, inspected, aliquoted, and made available for testing within required turnaround times
• Establish systems for scheduling, assigning, and tracking completion of QC tests and ensuring all data are approved by their scheduled completion date
• Ensure complete traceability for all GMP test samples from generation to disposal, including continuity between manual and computerized systems (e.g., LIMS)
• Manage outsourced testing at GMP contract testing laboratories, including shipment, tracking testing to completion, and review of resulting data
• Coordinate shipment and receipt of test samples, reference standards, and critical reagents between Seagen sites
• Hire, train, and mentor outstanding QC personnel, including management of shift-based and on-call staff
• Track, execute, and document annual inspection of reference standards, retains, and critical reagents
• Maintain inspection ready GMP laboratories, equipment, and records
• Collaborate with Engineering and Quality Assurance to establish effective alarm response protocols for controlled environment equipment
• Establish and track key performance indicators related sample management, turnaround time, contract testing, and QMS compliance
• Act as subject matter expert for procedures, change controls, investigations, and audits related to chain of custody and inventory management
• Identify and implement opportunities for continuous improvement in sample management, labeling, GMP shipping, alarm response, contract testing, or records management.

Expected Qualifications:

• 10+ years relevant GMP/QC experience
• Bachelor's degree or higher in relevant scientific discipline
• 2+ years of experience managing direct reports. Experiencing managing shift-based direct reports preferred
• Extensive knowledge of sample management and chain of custody requirements for GMP manufacturing and laboratory operations
• Demonstrated ability to plan and organize efficient operations in a high-throughput laboratory setting
• Experience with common QC laboratory equipment and software systems
• Ability to work collaboratively across departments and between sites to develop solutions that work for all stakeholders
• Quality Management System (QMS) experience that includes defining GMP compliant workflows, authoring and approving procedures, developing training curricula, change controls, investigations and CAPA, and risk management.

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 $117,000 to $151,800 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.

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: 12/23/2022