Senior Manager, Global Drug Substance Commercialization, Conjugation

Summary:

The Senior Manager for Drug Substance (DS) Commercialization has the responsibility for launch readiness and commercial supply of the conjugate drug substance. The conjugate product strategy will transition from the Process Development organization to Manufacturing Science and Technology (MSAT) during late-stage product development. This role focuses on technical launch planning and execution by bringing best-practices and coordinating cross-functional efforts for regulatory filings, facility readiness, and launch supplies.

This role also provides leadership to ensure that the organization is equipped to effectively communicate the scientific and commercial rationale for conjugation process to internal stakeholders, relevant CMOs, and to regulatory agencies. The incumbent will be highly skilled in written communication, especially in regard to authoring Health Authority submissions (IND/BLA). The role will also require the ability to interact effectively with people of diverse backgrounds and perspectives. The incumbent will also work with the organization to ensure on-time execution and appropriate planning for commercial lifecycle management.

This position will be reporting into the Director for Global DS Commercialization, Conjugation. The Sr. Manager will collaborate on overall program strategy, with primary responsibility and accountability for the drug substance strategy.

Manufacturing Science and Technology (MSAT) 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 Commercial Manufacturing and Supply Chain organization, MSAT 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 continuous improvement in process robustness throughout the.