Associate Director, Global Drug Substance Commercialization, Critical Raw Materials

Summary:

The Associate Director for Drug Substance (DS) Commercialization has the accountability for launch readiness and commercial supply of associated raw materials for production of eCRM and associated components for glycoconjugate vaccines. This role focuses on technical launch planning and execution by bringing best-practices and coordinating cross-functional efforts for regulatory filings, and commercial supply of associated raw materials for production of eCRM and associated components for glycoconjugate vaccines and post-launch process robustness initiatives.

This role also provides leadership to ensure that the organization is equipped to effectively communicate the scientific and commercial rationale for eCRM and associated raw material processes to internal stakeholders, relevant CMOs, and to regulatory agencies. The incumbent will work with the organization to ensure on-time execution and appropriate planning for commercial lifecycle management.

This position will be reporting into the Senior Director for Global DS Commercialization, Protein. The Associate Director will collaborate on overall program strategy, with primary responsibility for supporting development and execution of eCRM and associated raw material process strategy execution, including process troubleshooting, robustness study design and execution. The incumbent will also contribute to authoring of regulatory documentation and associated supporting documents.

Global Manufacturing Science and Technology (GMSAT) is responsible for successfully and seamlessly transitioning the vaccine process from Process Development to Commercial, developing and executing technical launch and commercialization strategy, continuously improving process robustness through to end of lifecycle, and ensuring best possible patient outcomes while creating value for the enterprise. As part of the Technical Operations organization, GMSAT will lead the technical and process support for end-to-end commercial manufacturing, including Polysaccharides, Carrier Proteins, Conjugation across all Drug Substances (DS). The range of activities will include DS technology transfer support, process characterization experiments in support of validation, process improvement, evaluation of novel process technologies, and investigation of process related manufacturing issues, ensuring