Seagen

Manager, External Manufacturing Operations - Packaging

Technical Operations & Process Sciences - Zug, Switzerland

Description

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 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 Packaging Operations. The 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

• Seagen’s contract and relationship owner for specified CMO(s) and the key point of contact between parties.
• Manage contract and work order negotiations, closely track the budget for contracted activities, navigate contractual disputes to resolution.
• Serve as Supplier Relationship Manager leading one or more internal Virtual Management Teams consisting of Quality, Supply Planning, Logistics, Labelling, Serialization and Manufacturing Sciences & Technology representatives.
• Align production scheduling with internal supply planning; Facilitate cross-functional team activities to drive resolution of operational issues, production delays, deviations, and ensure appropriate corrective actions are mutually agreed with specified CMO(s) and successfully executed.
• Track change controls to ensure that changes are successfully implemented in alignment with regulatory planning and supply constraints.
• Understand Seagen’s packaging operations processes; perform technical review of master packaging records, specifications, deviations, and change requests.
• Maintain in-depth understanding of the CMO’s systems, capabilities, capacities, requirements, and business practices.
• Monitor site performance according to Key Performance Indicators (KPIs); work to continuously improve the CMO’s performance in-line with Seagen’s expectations; lead or participate in periodic internal and external governance meetings.
• Participate in 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.
• Assist in efforts to evaluate and qualify new contract manufacturers.
• Work with Product Supply Leadership to assess risk and develop and execute Product Supply’s network manufacturing strategy.

Qualifications

• Minimum of five years industrial experience in the biopharmaceutical or pharmaceutical industry is required.
• Hands-on experience in packaging operations and managing launches 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.
• 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.
• Must possess excellent communication, project management, collaboration, and analytical skills.
• Ability to handle complex projects in 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.
• Thorough understanding of local compliance, as well as a sound ethical approach to business.

Education

• Degree in engineering, biotechnology, chemical engineering, or another relevant Life Science. PhD with 5 - 7 years of experience, MS or MBA with 6-8 years of experience, or Bachelor with 8+ years of experience is desired

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 05/06/2022