Manager, External Manufacturing Operations

**Manager, External Manufacturing Operations**

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.

Summary:
The Manager, External Manufacturing Operations is responsible for meeting Seagen’s supply demands, both clinical and commercial, at Contract Manufacturing Organizations (“CMOs”) they manage. The Manager, External Mfg Ops, 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.

Requirements or Responsibilities:

- Serve as the ”Supplier Relationship Manager” (SRM) for one or more CMOs.
- Lead cross-functional internal Virtual Management Teams (VMTs) consisting of representatives from Supply Operations, Quality, Manufacturing Sciences & Technology and Technical Development.
- Align CMO production scheduling with internal supply planning and drive resolution of operational issues such as investigations, deviations, corrective and preventive actions, production delays etc.
- Manage contract and work order negotiations, closely track the budget for contracted activities, navigate contractual disputes to resolution.
- Understand Seagen’s manufacturing processes; perform technical review of master and executed batch records, specifications, deviations, and change requests.
- Manage change planning and ensure timely implementation of changes in line with regulatory strategy and inventory management constraints.
- Maintain an in-depth understanding of the CMO’s systems, capabilities, capacities, requirements, and business practices, and be actively engaged in the CMO’s operations to ensure on-time, in-full delivery of clinical and commercial products.
- Monitor site performance according to Key Performance Indicators (KPIs); work to improve the CMO’s performance in-line with Seagen’s expectations.
- Lead periodic Operational Review Meetings and Executive Steering Committee 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.
- Contribute to recommendations for capacity expansion at contract manufacturers, as required.

Qualifications:

- Minimum of three years industrial experience in manufacturing operations, MSAT, supply chain, process development, project management, quality or similar functions in biopharmaceutical, pharmaceutical or chemical industry required.
- Hands-on experience in biologics or small molecule/API 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.
- 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 required. Some proficiency in French, German, Italian, Portuguese or Spanish is a plus.

**Education**:

- Degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or other relevant Life Science discipline. PhD with -3-5 years of experience, Masters with 5-8 years of experience, or Bachelors with 8+ years of experience is desired.