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 is seeking a highly motivated Principal Process Engineer (Manufacturing-DP) that desires an opportunity to significantly contribute to the development and commercialization of transformative cancer therapies. The initial focus of this position will be to actively participate and contribute to the design, build, and operational startup of 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).

Principal Responsibilities:

• Troubleshoot and resolve equipment and/or automation issues for various fill finish operations, including but not limited to parts washer, autoclave, pooling/mixing/filtration of drug product, filling, stoppering, capping, lyophilization, device assembly and packaging activities
• Lead FAT, SAT, commissioning and IQ/OQ of DP equipment
• Provide technical expertise to lead and close investigations, non-conformances, and corrective actions
• Identify process and technology gaps and issues; develop solutions and implementation plans
• Participate and support internal and regulatory authority facility audits and site inspections

Qualifications:

• S. in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering with minimum of 8 years of relevant experience
• In-depth knowledge of equipment, operations, and engineering principles related to biotherapeutic drug product manufacturing, including disposable technologies
• Intermediate level understanding of process automation (Wonderware and DeltaV) used for bioprocessing controls systems
• Knowledge of GdPs, cGMPs, and regulatory requirements including 21 CFR Parts 210 and 211, and ICH Q7
• Position requires excellent written and verbal communication skills and the ability to work with minimum direction
• Critical thinker with a comprehensive understanding of biologics regulatory requirements, risk management principles, and science-based decision making
• Capacity to develop solutions for technical issues of difficult scope

Preferred Qualifications:

• Experience with manufacturing processes that utilize single-use technologies and systems
• Working knowledge of ADC mAb conjugation processes
• Experience with isolators and/or RABS fill machines
• Experience in helping to build and maintain a Manufacturing Operations infrastructure in a fast-paced and growing company
• Experience with equipment factory and site acceptance testing, commissioning/validation activities

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 $141,000 to $183,000 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.

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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