Senior Manager, Commercial MSAT, Polysaccharide

About the role

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.

Responsibilities

• Provide strategic and scientific leadership for polysaccharides with internal and external stakeholders and ensure successful execution of launch plans and post-launch commercial activities.
• 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.
• Continuously improve process understanding and process robustness using staff and laboratory resources across the organization to monitor, trend, and optimize operations.
• Collaborate 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.
• Ensure robust processes exist to support technical transfers and integration of new technologies.
• Support the internal and external manufacturing network, including materials management and data analytics.
• 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.
• Engage in technical reviewing and authoring of regulatory filings and respond 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 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.
• 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%.

Requirements

• Minimum of 5+ years of relevant experience for a degree in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline; 8+ years for a Master’s degree; 12+ years for a Bachelor’s degree.
• 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.