Senior Manager, Clinical Packaging Operations, Europe
Responsible for planning and management of global, clinical supply. Includes oversight of CMO scheduling, comparator sourcing, analysis and reporting of production performance, analysis of clinical supply/demand trends, and creation and implementation of product packaging timelines. Responsible for advanced, complex, clinical supply planning and issue resolution. Expected to have extensive knowledge across many functional areas and resources related to global clinical supply operations. Acts as business coordinator for third party relationships. Works closely with all internal and external resources to optimize clinical supply availability and inventory investment.
- Applies Good Manufacturing Principles in all areas of responsibility.
- Responsible for overseeing primary and/or secondary operation within clinical packaging.
- Assist with the lot information and tracking of inventory by study by country
- Monitor the inventories of clinical product, including comparator drug at the distribution points
- Prepare and distribute periodic status reports on clinical drug product inventories, and planned production
- Provides timely and accurate clinical inventory information to the required systems
- Assist in the maintenance of the IWRS/IRT inventory database
- Recommend changes to labeling/packaging schedules for SGEN clinical drug products based on progress
- Provide liaison between SGEN teams and the Clinical Operations group
- Acts as an effective Change Leader, supporting change management and continuous improvement in the department.
- Develop and communicate accurate lead time requirements to our packaging/distribution vendors as well as the internal SGEN teams as required.
- Manage the development of packaging plans/schedules and track/report against actual performance
- Acts as point of contact for third party vendors
- Performs other duties as assigned to meet the needs of business
- BS/BA Degree in a business or scientific field and/or a minimum of 7+ years of product supply including a minimum of 5 years of experience in labeling, packaging, and distribution of clinical trial materials.
- Experience in an FDA regulated atmosphere.
- Experience in managing diverse project activities with manufacturing facilities at different geographical locations
- Experience working in a multi-cultural, multi-lingual environment
- Excellent verbal and technical written communication skills, excellent interpersonal skills, and negotiation skills are essential.
- Strong project management abilities
- Demonstrated ability to contribute successfully in a multi-disciplinary team environment / matrix organization
- Experience working with an enterprise level planning system. (SAP, Oracle etc.)