Senior Manager, Commercial MSAT, Polysaccharide

This is a fully remote position, open to applicants in California.

📋 Description

• The Senior Manager, Commercial MSAT for Polysaccharides will oversee and facilitate the readiness for launch and commercial supply of polysaccharides utilized in glycoconjugate vaccines.

• This position emphasizes technical launch planning and execution, incorporating best practices while coordinating cross-functional efforts for regulatory submissions, facility preparation, and launch supplies.

• The role also entails providing leadership to ensure the organization is well-equipped to effectively convey the scientific and commercial rationale for essential raw material manufacturing processes to internal stakeholders, relevant CMOs, and regulatory agencies.

• The incumbent will collaborate with the organization to guarantee timely execution and appropriate planning for commercial lifecycle management.

• The Senior Manager will work on the overall program strategy, holding primary responsibility and accountability for the polysaccharide drug substance intermediate.

⛳️ Requirements

• A degree in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or a related field, with a minimum of 5+ years of relevant experience for Ph.D. holders, 8+ years for M.S./M.A. holders, or 12+ years for B.S./B.A. holders.

• Experience in the development, tech transfer, scale-up, or production of polysaccharide/protein conjugate vaccines.

• Extensive knowledge of biologic production processes, including bacterial fermentation, recovery, and purification across various operational scales.

• Experience in MSAT or Process Development in matrixed team roles.

• Ability to leverage deep technical expertise collaboratively to formulate strategic plans and achieve mutual objectives.

• Exceptional organizational, problem-solving, and strategic planning abilities.

• Highly proficient in both verbal and written communication, capable of effectively engaging with individuals from diverse backgrounds and perspectives.

• Proactively identifies needs and potential challenges, directing activities to implement effective solutions.

• Proficient in seeking and analyzing data from various sources to inform decisions and align others with the organization's overarching strategy.

• Familiarity with Raman spectroscopy and off-gas analyzers, as well as their application in process monitoring and manufacturing operations, is preferred.

• Experience with data visualization tools and techniques to support analysis, trending, and decision-making is advantageous.

• An entrepreneurial and innovative mindset for developing new ideas that challenge the organization and push industry boundaries.

🏝️ Benefits

• The compensation package will be competitive and encompasses comprehensive benefits along with an equity component.