Manager External Manufacturing Operations
The Manager, External Manufacturing Operations is responsible for meeting Seagen’s supply demands, both clinical and commercial, at Contract Manufacturing Organizations (“CMOs”) specializing in the production of small molecule intermediates, drug-linkers, APIs, and/or drug products. 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 on-time delivery.
- Seagen’s contract and relationship owner for specified CMOs 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 “Virtual Plant Manager” leading one or more internal Virtual Plant Teams consisting of Technical Development, Quality, Planning, Logistics, and Manufacturing Sciences & Technology representatives
- Align production scheduling with internal supply planning; assist and drive resolution of operational issues, production delays, deviations, and corrective actions
- Track change controls to ensure that changes are successfully implemented in alignment with regulatory planning and supply constraints
- Understand Seagens’ small molecule manufacturing processes; perform technical review of master and executed batch 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 improve the CMO’s performance in-line with Seagen’s expectations; lead or participate in periodic Business Review 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
- Minimum of five years industrial experience in the biopharmaceutical or pharmaceutical industry is required
- Direct experience developing and negotiating contracts with external suppliers is a plus
- 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
- Ability to handle complex projects in fast-changing, challenging environment
- Ability to travel within and outside of the US with occasional periods of frequent travel
Education:Degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or other relevant Life Science. PhD with 5 - 7 years of experience, MS or MBA with 6-8 years of experience, or Bachelors with 8+ years of experience is desired
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.
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.