Senior Manager, Commercial MSAT, Polysaccharide

Summary:

The Senior Manager, Commercial MSAT for Polysaccharides will lead and facilitate launch readiness and commercial supply of the polysaccharides used in glycoconjugate vaccines. 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 critical raw material manufacturing 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 to the Director, Commercial MSAT for Polysaccharides. The Senior Manager will collaborate on overall program strategy, with primary responsibility and accountability for the polysaccharide drug substance intermediate.

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 Technical Operations organization, MSAT will lead the technical and process support for end-to-end commercial manufacturing, including Polysaccharides, Carrier Proteins, and Conjugation across all Drug Substances (DS). The range of activities will include technology transfer support, process characterization experiments in support of validation, process improvement, evaluation of novel process technologies, investigation of process related manufacturing issues, ensuring continuous improvement in process robustness throughout the product life cycle, etc.

Essential Functions:

• DS Commercialization – Provide strategic and scientific leadership for polysaccharides with internal and external stakeholders and ensure successful execution of launch plans and post-launch commercial activities.
• Organization – Build a strong and highly-skilled team for the global network with special focus