Seagen

Senior Specialist External Manufacturing Operations Drug Linker

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 Sr. Specialist is part of a team responsible for meeting Seagen’s supply demands, both clinical and commercial, at Contract Manufacturing Organizations (“CMOs”) with an emphasis on small molecule chemical manufacturing. The Sr. Specialist works closely with the External Manufacturing Operations (EMO) staff and cross-functional team members to achieve uninterrupted supply while ensuring excellence in quality and compliance.

Principal Responsibilities

• Work with manager and director-level EMO staff on an array of tasks related to manufacturing planning and execution, post-production activities, data management, and Logistics.
• Contribute to resolve operational issues, production delays, deviations, and corrective actions.
• Support contract work (new agreements, work orders, amendments) by liaising with EMO management and Legal. Support issuance and of purchase orders and payments as needed liaising with Planning, Purchasing, and relevant approvers.
• Learn and become proficient at Seagen Quality systems. Review and track deviations, change controls, and corrective actions to ensure progress and on time completion.
• Gain understanding of Seagen’s small molecule manufacturing processes; perform technical review of master and executed batch records, specifications, and change requests.
• Maintain in-depth understanding of the CMO’s systems, capabilities, capacities, requirements, and business practices.
• Assist the team to monitor site performance according to Key Performance Indicators (KPIs); may participate in periodic Business Review Meetings.
• Participate in cross-functional teams as requested to support projects/initiatives related to manufacturing operations. Such projects may include technology transfers, process improvements, validation-related activities, regulatory submission reviews, or project management.
• May be involved in evaluation and qualification of new contract manufacturers.

Qualifications

• Minimum of five years industrial experience in the biopharmaceutical or pharmaceutical industry is required
• Hands-on experience in small molecule process development or manufacturing is required; experience with highly potent (HiPo) manufacturing is a plus
• 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
• Experience working at or with CMOs on a broad range of projects including support of commercial and/or clinical manufacturing in a cGMP environment
• Ability to handle complex projects in fast-changing, challenging environment
• Direct experience developing and negotiating contracts with external suppliers is a plus
• Ability to travel within Europe and US occasionally, with occasional periods of frequent travel
• Fluency in English, some proficiency in Dutch, Spanish, Portuguese, French, German or Italian is a plus

Education

• Degree in chemistry, chemical engineering, biotechnology, or another relevant Life Science. PhD or MS with 2 years of relevant experience, or Bachelor’s with 5+ years of experience is desired.

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 08/12/2022