Director Site Supply Operations

vor 2 Wochen

Zug, Schweiz Seagen Vollzeit

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:
Principal Responsibilities:

- Is an integral member of Global Supply Operations with supply chain oversight of (i) commercial manufacturing from critical raw materials to finished goods and (ii) clinical manufacturing from critical raw materials to drug product
- Leads team of Site Supply Chain Associate Directors, Senior Managers, Managers, and Associates, including staff coaching and guidance. Team is in the US and in Europe. Grows team as directed by business scope
- Acts as Global Supply Operations point of contact across CMOs, develops strong business relationships, and advocates for Seagen interests
- Leads timely and comprehensive communication of forecast, purchase orders, quantity and leadtime requirements to appropriate internal and external stakeholders
- Co-leads product lifecycle by translating strategy into site supply chain plans and oversees successful execution
- Oversees artwork and label operations, including planning and execution of label changes as driven by Regulatory submissions and timelines. Represents TOPS on the Regulatory Label Working Group. Ensures continuous integration of labeling revisions to global planning process
- Manages internal team to support serialization operations worldwide. Ensures Seagen and the CMO operations remain in full compliance with US Drug Supply Chain Security Act, EU Falsified Medicines Directive, and other applicable serialization regulations
- Consistently demonstrates skills for evaluating customer needs and offering alternatives to accomplish the program’s goals
- Develops and executes annual budget as guided by corporate plans
- Measures site supply chain, artwork, labeling, and serialization performance and proactively takes measures to course correct as needed
- Co-leads supply chain systems and process implementation
- Works closely with internal and external resources to optimize supply availability and inventory investment
- Assists in technical problem solving and partners with CMOs and Quality to resolve technical and compliance issues
- Leads and execute high-profile Supply Operations projects
- Acts as Site Supply Chain representative for recall planning process/team
- Is an active participant on commercial launch, and CMC teams

Qualifications:

- A minimum of 10+ years working in a global biopharmaceutical Supply Chain or related industry
- A minimum of 5-8 years working within a pharmaceutical environment
- In-depth functional knowledge of site supply chain, artwork management, labeling, and serialization operations
- Working experience in commercial supply product launches
- Demonstrated knowledge of global manufacturing regulations and best practices, including DSCSA/FMD requirements
- Experience and knowledge of cGMPs in an FDA regulated environment
- Experience working within an integrated enterprise level planning system (Oracle preferred)
- Ability to travel in the US and Europe, occasional periods of frequent travel#LI-LO1

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