Senior Manager, Commercial MSAT, Polysaccharide

🔥 10 horas atrás

🏄 California – Remoto

🏄 California – Remote

💵 $165.000 - $193.000 / ano

⏰ Tempo Integral

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👔 Gerente

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Vaxcyte

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2013

🧬 Biotecnologia

💊 Farmacêutico

Biotechnology • Pharmaceuticals

A Vaxcyte é uma empresa inovadora em vacinas em estágio clínico, projetando vacinas de alta fidelidade para prevenir e tratar infecções bacterianas graves. A empresa desenvolve vacinas conjugadas de amplo espectro e novas vacinas de proteína—utilizando química sintética moderna e uma plataforma proprietária de síntese de proteínas sem células licenciada da Sutro Biopharma—para criar antígenos de proteínas difíceis de serem produzidos de forma mais eficiente. Seus programas principais são os candidatos a vacina conjugada pneumocócica VAX-31 (31-valente) e VAX-24 (24-valente) em estudos de Fase 2/3, com candidatos em estágio inicial direcionados ao Grupo A Strep e Shigella; a Vaxcyte foca na redução da carga de doenças bacterianas invasivas, consequências da resistência a antibióticos e morbidade relacionada em populações vulneráveis.

Descrição

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

🎯 Requisitos

• 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.

🏖️ Benefícios

• The compensation package will be competitive and includes comprehensive benefits and an equity component.