Description

Description

Position at Seagen

Seagen is a global multi-product biotechnology company that develops and commercializes innovative therapies for the treatment of cancer. The company's industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to four marketed products, we are advancing a strong product pipeline of novel therapies for solid tumors and blood related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients. More information about Seagen can be found at www.Seagen.com

Position Summary:

The Senior Specialist, 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 Senior Specialist focuses on achieving uninterrupted supply while ensuring excellence in quality and compliance. Results are obtained via direct collaboration with internal stakeholders to coordinate and track production planning, execution, issue resolution, and on-time delivery.

Principal Responsibilities:

• Provide support to 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
• Support contract and work order negotiations, closely track the budget for contracted activities, assist the Virtual Management Teams in contractual disputes to resolution
• 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; 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 or project management
• Assist in efforts to evaluate and qualify new contract manufacturers

Qualifications:

• Minimum of five years industrial experience in the biopharmaceutical or pharmaceutical industry is required
• Hands-on experience in large 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 French, German or Italian is a plus
• thorough understanding of local compliance, as well as a sound ethical approach to business

Education:

• Degree in in biotechnology, chemical engineering, or another relevant Life Science. PhD with 2 years of experience, MS or MBA with 4 years of experience, or bachelor's with 5+ years of experience is desired

As a leading employer in our industry, 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. To learn more about Seagen, please visit www.Seagen.com.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment.

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