Msat Validation Jobs (NOW HIRING)

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. 

• 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 on polysaccharide manufacturing processes. Support resourcing recommendations on staffing requirements to meet organizational goals.
• Process robustness - Continuously improve process understanding and process robustness using staff and laboratory resources across the organization to monitor, trend, and optimize operations.
• Interface - Collaboration with cross-functional teams across the network, including Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering, to drive the successful development and commercial launch of carrier proteins for pipeline products.
• Tech-transfer new technologies - Ensure robust processes exist to support technical transfers and integration of new technologies.
• Support technical services - Support of our internal and external manufacturing network, including materials management and data analytics.
• Process validation and comparability - Provide leadership for the execution of process validation and process comparability activities. Effectively communicate the scientific and commercial rationale for polysaccharide processes to the Manufacturing organization for commercialization
• Regulatory - Engage In technical reviewing and authoring of regulatory filings and responding to questions received from health authorities. Effectively communicate the scientific and commercial rationale for polysaccharide processes to the Boards of Health for regulatory submissions for commercialization.
• Communicate - Effectively and efficiently communicate process performance to key stakeholders (internal-facing and external-facing). Connect and build strong working relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.
• Leadership - Contribute as a member of the polysaccharide governance teams, with an aim to ensure effective and efficient delivery of our life-enhancing therapies to our patients.
• Travel - 10-30% travel required.

• Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with a minimum of 5+ years of relevant experience for Ph.D., 8+ years for M.S./M.A., or 12+ years for B.S./B.A.
• Experience in development, tech transfer, scale-up or production of polysaccharide/protein conjugate vaccines
• Extensive experience in biologic production processes, including bacterial fermentation, recovery, and purification across multiple operational scales.
• Experience in MSAT or Process Development in matrixed team roles.
• Able to leverage deep technical knowledge in a collaborative manner to establish strategic plans and achieve collective goals.
• Excellent organization, problem solving and strategic planning skills.
• Highly skilled in both verbal and written communication with the ability to interact effectively with people of diverse backgrounds and perspectives.
• Proactively recognizes needs and potential challenges, and directs activities to implement effective solutions.
• The ability to seek and analyze data from a variety of sources to support decisions and to align others with the organization's overall strategy.
• Experience with Raman spectroscopy and off-gas analyzers, and their application to process monitoring and manufacturing operations is desirable.
• Experience with data visualization tools and techniques to support analysis, trending, and decision-making is desirable.
• An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.