Senior Manager, Microbiology Support – Global ASAT

🕒 Maio 21

🏄 California – Remoto

🏄 California – Remote

💵 $166.000 - $194.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 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

• Serve as the technical expert for QC microbiological assays. • Support the authoring and review internal SOPs related to microbial Quality Control policies and procedures. • Responsible for quality event management related to microbiology QC and aseptic manufacturing operations. • Manage outsourced cGMP and characterization testing supporting lot release. • Collaborate with Analytical Development, Quality Control, and Product Development and interface with key stakeholders. • Apply technical and compliance expertise to the review of test methods and provide feedback. • Work with others to identify opportunities for continuous improvement and implement solutions. • Provide strong teamwork in establishing a quality culture and shared accountability.

🎯 Requisitos

• Degree(s) in Microbiology, Biology, Biochemistry, or related discipline with a minimum of 7+ years of relevant experience for Ph.D., 9+ years for M.S./M.A., or 11+ years for B.S./B.A. • 7+ years of experience in Pharma / Biotech industry in aseptic manufacturing or microbiology required. • Understanding of various analytical methodology principles and experience with GMP release testing. • Knowledge of microbial control methods (e.g. Bioburden, Endotoxin, Sterility, Growth Promotion). • Previous experience in analytical method verification, development, validation and transfer is highly desirable. • Experienced leading investigations into microbiological non-conformances (deviations, out-of-specification results). • Solid understanding of relevant cGMPs, FDA, EU, and ICH regulatory guidelines as applicable to QC operations/aseptic processing/manufacturing sterility assurance, and/or compendial methods (USP/EP/JP). • Result oriented; good judgment in directing attention and effort across competing priorities. • Highly skilled in both verbal and written communication with the ability to interact effectively. • Ability to work globally with CMOs in different countries and continents.

🏖️ Benefícios

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