Seagen

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:

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 Associate III, Quality Document Control is primarily responsible for supporting the GMP Document Control Program and providing guidance for the Everett, WA site. The Associate III works with their team and may serve as an advisor to internal customers to ensure routine technical work is completed to high quality standards and on schedule. 

Full understanding of area of specialization, functional knowledge of other related disciplines, and developing ability to merge ideas across disciplines is required. This role typically works closely with internal team members and cross-functional teams within Everett (i.e., Operations, Quality Control, Technology, Engineering, Facilities and Quality Assurance.) 

Principal Responsibilities:

• Make independent decisions within Quality Program following approved procedures and established methodologies, with support from management on issues of moderate complexity and/or moderate risk 
• Define, produce, and present key system and site performance metrics to monitor Quality Program training effectiveness and drive improvement. Provide regular reports to management and governance teams 
• Support implementation of Quality Program requirements at the site 
• Represent Quality Systems on internal teams 
• Provide logistical support for inspections and audits 
• Assist with the resolution of regulatory/audit commitments 
• Responsible for all Quality Program administration activities including site use of the eQMS 
• Assist in the revision/completion GMP documents (i.e., operating procedures, task instructions, forms) and QMS documents within scope of the Quality Program 
• Create, improve, maintain, and deliver site and team trainings for performance of the Quality Program 
• Support training and mentoring for Quality Program staff 
• Provide guidance and tools to support internal customers 
• Author and own QMS records for issues of low complexity/risk, and ensure each is completed to high quality standards and on schedule 
• Actively seek out, champion, support, and implement process and system improvements 
• Provide backup support for other site Quality Programs, as required 
• Participate in on-call rotation to provide after-hours support of GMP operations, as required 
• Other duties, as assigned 

Expected Qualifications:

• 5+ years in GMP operations, preferably in the biopharmaceutical or pharmaceutical industry 
• Bachelor's degree in relevant field; or Associate's degree +2 additional years of relevant experience in the biopharmaceutical or pharmaceutical industry 
• Intermediate knowledge of cGMP and ability to understand and independently apply ICH, regulatory, and pharmaceutical organization guidance to standard work 
• Intermediate knowledge of industry practices and standards, and ability to independently apply to standard work 
• Proficient use of Microsoft Office 365 for managing standard work 
• Proficient use of applicable systems software (e.g., Learning Management System, electronic Quality Management System, data analytics, etc.) 
• Advanced written and oral communication skills 
• Demonstrated problem-solving skills and techniques commensurate with job level 
• Ability to manage routine and non-routine workload with moderate oversight 

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 $88,000 to $114,000 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 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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