Senior Manager External Manufacturing Operations

Description

Position at 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:

The Sr. Manager, External Manufacturing Operations is responsible for meeting Seagen's supply demands, both clinical and commercial, at Contract Manufacturing Organizations ("CMOs") with an emphasis on Large Molecule manufacturing. The Sr. Manager is the CMO's primary point of contact and focuses on achieving uninterrupted supply while ensuring excellence in quality and compliance. Results are obtained via direct collaboration with the CMO and internal stakeholders to coordinate and track production planning, execution, issue resolution, and ensure on-time release and delivery.

Principal Responsibilities:

• Owns Seagen's contract and relationship for specified CMO(s) and is key point of contact between parties
• Manages complex contract and work order negotiations with autonomy, closely tracks the budget for contracted activities, navigates contractual disputes to resolution
• Serves as Supplier Relationship Manager leading one or more internal Virtual Management Teams consisting of Technical Development, Quality, Planning, Logistics, and Manufacturing Sciences & Technology representatives
• Serves as Manufacturing Operational Team Lead and coordinates internal governance meeting to deliver End to End Manufacturing and Supply oversight for specific program
• Aligns production scheduling with internal supply planning; Facilitates cross-functional team activities to drive resolution of operational issues, production delays, deviations, and ensures appropriate corrective actions are mutually agreed with specified CMO(s) and successfully executed
• Tracks change controls to ensure that changes are successfully implemented in alignment with regulatory planning and supply constraints
• Understands Seagen's large molecule manufacturing processes; perform technical review of master and executed batch records, specifications, deviations, and change requests
• Maintains in-depth understanding of the CMO's systems, capabilities, capacities, requirements, and business practices
• Monitors site performance according to Key Performance Indicators (KPIs); works to continuously improve the CMO's performance in-line with Seagen's expectations; leads or participates in periodic internal and external governance meetings
• Participates in / Leads cross-functional teams to drive projects related to manufacturing operations. Such projects may include technology transfers, process improvements, validation activities, regulatory submission reviews, associated change management and project management
• Assists in efforts to evaluate and qualify new contract manufacturers
• Works with Product Supply Leadership to assess risk and develops and executes Product Supply's network manufacturing strategy

Qualifications:

• A minimum of ten years industrial experience in the biopharmaceutical or pharmaceutical industry is required
• Must have competent knowledge of cGMP's for pharmaceutical manufacturing
• Must have competent knowledge of quality systems, including investigations, corrective actions, and change management
• Must possess excellent communication, project management, collaboration, and analytical skills
• Hands-on experience in large molecule process development or manufacturing is required; experience with highly potent (HiPo) manufacturing is a plus
• Experience working at or with CMOs on a broad range of projects including support of commercial and/or clinical manufacturing in a cGMP environment
• Direct experience developing and negotiating contracts with external suppliers is a plus
• Ability to handle complex projects in a fast-changing, challenging environment
• Ability to travel within Europe and US occasionally, with occasional periods of frequent travel
• Fluency in English, some proficiency in French, German, Italian, Portuguese, or Spanish is a plus

Education:

• Degree in engineering, biotechnology, chemical engineering, or another relevant Life Science

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 $133,000 - $171,600 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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