Seagen

Quality Assurance Specialist External Quality

Corporate Functions - 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:

This position will support the manufacturing and testing of clinical and commercial GMP materials with a focus on batch / lot review. The role reports into the Associate Director of US External Quality. The role sits within a growing External Quality team that is part of our expanding Global Center of Excellence focused on External Manufacturing and Testing.

Principal Responsibilities:

• Manage lot review activities for clinical and commercial GMP Intermediates, APIs, and Drug Products to ensure disposition timelines are met
• Perform technical disposition of clinical and commercial GMP Intermediates, APIs and Review and manage deviations from contractors related to manufacturing and testing
• Review executed batch production records to ensure compliance with approved procedures, quality agreements and GMP expectations
• Communicate and resolve discrepancies with CMOs
• Compile and manage lot files
• Contribute to relevant PQR sections
• Participate in quality system improvements
• Revise standard operating procedures and associated work instructions. Authoring SOPs is also possible under supervision
• Monitoring local and global team meetings and project progress to ensure efficient and effective communication on project status and issues

Required Qualifications:

• Minimum of Bachelor’s degree in a scientific discipline (Chemistry, Microbiology, etc.) – 8 + years’ experience in the pharmaceutical industry
• Ability to travel domestically and internationally 20% of time  8+ years relevant GMP Experience

Preferred Qualifications:

• Knowledge and experience with US/EU GMPs, ICH and other applicable international regulations
• Experience with the production and testing of pharmaceuticals (biologic or small molecules)
• Experience working with CMOs (Contract Manufacturing Organizations) preferred
• Excellent communication skills and proven ability to work well with internal and external teams
• Experience with electronic documentation management systems preferred
• Ability to prioritize work and handle multiple assignments, while maintaining a high level of quality

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 $98,000 to $126,500 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