Senior Manager, Commercial MSAT, Polysaccharide

🕒 vor 8 Tagen

🏄 California – Remote

🏄 California – Remote

💵 $165.000 - $193.000 / Jahr

⏰ Vollzeit

🟠 Senior

👔 Manager

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

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Vaxcyte

WebsiteLinkedInAlle Stellen

201 - 500 Mitarbeiter

Gegründet 2013

🧬 Biotechnologie

💊 Pharmazie

Biotechnology • Pharmaceuticals

Vaxcyte ist ein Unternehmen für Impfstoffinnovation in der klinischen Phase, das Hochpräzisions-Impfstoffe zur Verhütung und Behandlung schwerer bakterieller Infektionen entwickelt. Das Unternehmen entwickelt Breitband-Konjugat- und neuartige Proteinimpfstoffe, indem es moderne synthetische Chemie und eine proprietäre zellfreie Proteinproduktionsplattform nutzt, die von Sutro Biopharma lizenziert wurde, um schwer herzustellende Proteinantigene effizienter zu erzeugen. Die Hauptprogramme sind die Pneumokokken-Konjugat-Impfstoffkandidaten VAX-31 (31-valent) und VAX-24 (24-valent) in Phase-2/3-Studien, mit weiteren Kandidaten in frühen Entwicklungsstadien, die auf Gruppe-A-Strep und Shigellen abzielen. Vaxcyte konzentriert sich darauf, die Belastung durch invasive bakterielle Krankheiten, die Folgen von Antibiotikaresistenzen und damit verbundene Morbidität in gefährdeten Bevölkerungsgruppen zu reduzieren.

Beschreibung

• 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.

🎯 Anforderungen

• 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.

🏖️ Vorteile

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