Manufacturing Compliance Specialist

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:

The Manufacturing Compliance Specialist supports internal manufacturing cGMP compliance with existing operations at the North Creek Manufacturing Facility. This position partners with internal manufacturing groups to help maintain compliance with cGMP regulations and support manufacturing operations by helping draft and revise documentation, develop and implement training, and implement continuous improvement methodologies that promote inspection readiness for a regulated commercial cGMP environment.

Principal Responsibilities:

• Perform manufacturing compliance oversight of the GMP manufacturing areas at the North Creek Manufacturing facility. Evaluate manufacturing equipment, systems, procedures, and operations for gaps; facilitate modifications and best practices to ensure manufacturing compliance to written procedures and regulations; drive ongoing improvements to ensure cGMP compliance and audit/inspection readiness
• Partner with the Manufacturing and Quality Operations groups acting as a liaison ensuring alignment with quality directives and promoting internal manufacturing best practices and improvements to facilitate manufacturing readiness for internal and external quality audits/inspections. Participate directly in internal, external, and global health authority audits/inspections
• Develop knowledge assessments to test personnel understanding and comprehension of key concepts and information within instructions outlined in manufacturing operating procedures
• Create and revise standard operating procedures (SOPs), deviation investigations and other manufacturing documentation as appropriate.
• Facilitate cohesive organization and delivery of information for effective learning and training of personnel
• Provide mentorship and training for the improvement of technical writing proficiency within Manufacturing. Assist with the development of templates for generating consistent, high quality write-ups/investigations for deviations, CAPAs, and change controls
• Participate and support a culture of continuous improvement utilizing expertise to help implement best practices promoting quality risk management and operational excellence principles
• Participate in investigations of safety or quality issues as necessary
• Effectively collaborate with cross functional partners such as Quality Assurance, Quality Control, Supply Chain, and Facilities as necessary

Expected Qualifications:

• High School Diploma / Associates Degree with exposure to science & math coursework
• 5+ years of relevant biopharmaceutical industry experience
• 3+ years of direct manufacturing or quality experience with cGMP production of biologics
• Experience leading deviation investigations
• Excellent technical writing skills including drafting of standard operating procedures and/or other documentation
• Passionate learner with exceptional initiative who is able to acquire knowledge, understand new equipment and processes, and organize necessary information to teach others effectively
• Demonstrated leadership and organizational abilities with regard to project management with the ability to influence and engage peers
• Demonstrated ability and experience working in cross-functional teams
• Able to work equally well as part of a team or independently
• Excellent oral and written communication skills
• Skills in problem solving and troubleshooting
• Proficient with MS Office suite (Word, Excel, PowerPoint)

Preferred Qualifications:

• BA/BS degree in a scientific discipline (life sciences / engineering)
• 7+ years of relevant biopharmaceutical industry experience with cGMP production of biologics
• Strong knowledge of cGMPs for drug substance manufacturing of biologics
• cGMP audit experience
• Recognized as a knowledgeable resource on a range of manufacturing and compliance topics
• Knowledgeable of applicable business systems including: MRP, LIMS, EAMS, QMS
• Previous experience with single use technology in the biopharmaceutical industry

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.

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.

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