Process Engineering Director jobs in Bellevue, WA

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 Associate Director is part of the technical leadership team tasked to enable and support production of Seagen’s clinical and commercial products at North Creek. This role is responsible for establishing and leading the process engineering function which provides support to manufacturing operations, new capabilities and technology implementation, process data collection, deviation investigations and change management, continuous improvement initiatives, and capital projects. The incumbent is a subject matter expert in biopharmaceutical operations and processing equipment. Incumbent will be versed in equipment design, installation and qualification, asset lifecycle management, and has thorough understanding of process equipment integration with different automation and control platforms. The ideal candidate has a proven track record leading process engineering projects, displaying creativity, technical expertise, and cross-functional collaboration.

Principal Responsibilities

• Build, lead, and manage a manufacturing process engineering team, providing technical support specific to antibody intermediate and DS processes and equipment
• Partner in technical/process transfers from internal and external sources
• Troubleshoot and resolve process, equipment issues in the field
• Develop and issue cGMP compliant design documents and protocols
• Provide technical expertise to lead and close investigations, non-conformances, and corrective actions
• Provide technical and team leadership for process engineering tasks and initiatives across Seagen manufacturing sites
• Work in collaboration with MSAT, Technical Development, Manufacturing, and Facilities teams to support the implementation of new manufacturing capabilities, technologies, process automation, and control systems
• Assist in the generation of relevant regulatory submissions
• Identify process and technology gaps and issues; develop solutions and implementation plans
• Participate and support internal and regulatory authority facility audits and site inspections
• Provide strong leadership, guide, and mentor staff to ensure productive and collaborative organizational performance and individual career growth
• Contribute to the design of new equipment and systems. Support specification development, supplier screening and selection, installation and qualification, asset ownership and lifecycle management
• Support minor and major capital projects, including equipment and facility updates, expansions, new facility planning and design, systems qualification, and start-up. Work with IT, Facilities, and other internal groups to ensure process and equipment requirements fit SeaGen standards and building and utilities capabilities
• In collaboration with Data Sciences, MSAT, and Manufacturing, support and drive improvements related to manufacturing process data collection, monitoring capabilities, and data trending
• In collaboration with MSAT, support and lead initiatives and changes aimed to improve yield, cycle times, process robustness, decrease cost and reduce risk
• Ensure that Quality systems related tasks are closely managed, including training, investigations, change controls, and corrective actions
• Hire direct-line reporting staff. Working closely with leadership, develop strategic plans and priorities for the Process Engineering group. Ensure all high priority tasks are properly resourced
• Ensure the team actively supports the implementation of best practices, procedures, and technologies. Drive a philosophy of operational excellence, continuous improvement, and risk reduction

Required Qualifications

• 10-15 years of experience in a life science regulated industry (pharmaceutical or biotech)
• BS/MS degree in Biochemical Engineering, Biotechnology, or Life Science; relevant experience will be considered
• In-depth knowledge of equipment, operations, and engineering principles related to biotherapeutic antibody intermediate and drug substance manufacturing, including disposable technologies
• Exceptional leadership skills to thoughtfully guide teams and individuals
• Significant contributor to multi-disciplinary teams at the functional level; mentors and provides technical leadership to individuals within the team
• Key competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making; and teamwork
• 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
• Demonstrated close partnership with cross-functional groups (Technical Development/Mfg/MSAT/Quality/Facilities) to ensure uninterrupted and compliant product supply.
• In-depth knowledge of US and applicable global regulations including ICH Q10, 21CFR210&211, Eudralex Volume 4, EU Annex 1, and GAMP 5
• Proven leadership ability to carry out difficult tasks in a logical and rational manner
• Demonstrated ability to communicate effectively to internal and external teams at all levels

Preferred Qualifications

• Experience with manufacturing processes that utilize single-use technologies and systems
• Working knowledge of ADC mAb conjugation processes
• Experience in helping to build and maintain a Mfg. Operations infrastructure in a fast-paced and growing company
• Demonstrated success effectively leading a process engineering function supporting clinical and commercial cGMP biologics manufacturing
• Expert knowledge in cGMP bioprocessing equipment and utility systems.
• In-depth experience with automation processes, control systems programming for manufacturing equipment, SCADA and DCS systems and related components (PLCs, HMIs, servers, and data historians)
• Well-versed in data integrity requirements and application in bioprocessing and data management including electronic batch records
• Direct experience with high-potency manufacturing and equipment; close understanding of containment requirements and controls
• Direct exposure / experience with health authority inspections

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 $164,000 - $212,000 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.

#LI-KC1