Seagen
Manager Manufacturing
Technical Operations & Process Sciences - Bothell, United States
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 large molecule manufacturing. 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.
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 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 Seagen’s large 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
Qualifications:
- 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 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
- 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 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 in 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
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 $116,000 - $149,600 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.
Apply:
Seagen
Seagen is an Equal Opportunity Employer
Submitted: 09/01/2023
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