Associate Director, Process Validation, Risk Management

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🕒 Abril 3

🏄 California – Remoto

🏄 California – Remote

💵 $174.000 - $203.000 / ano

⏰ Tempo Integral

🟠 Sênior

🔒 Seguros

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Vaxcyte

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2013

🏥 Saúde

🏭 Manufatura

🧬 Biotecnologia

Healthcare • Manufacturing • Biotechnology

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

• Lead and facilitate commercial process validation and risk management activities across Vaxcyte’s end-to-end manufacturing processes. • Provide leadership to ensure the organization is equipped to effectively design, execute, and communicate process validation and risk management strategies to internal stakeholders, external partners, and regulatory agencies. • Report to the Sr. Director of Process Validation within the Global MSAT organization and collaborate on overall validation strategy. • Provide strategic and scientific leadership for process validation across commercial programs. • Lead and facilitate execution of validation strategies to support technology transfer, site readiness, and product launch. • Ensure alignment of validation activities with regulatory expectations and lifecycle management plans. • Develop and implement risk management frameworks, tools, and processes in collaboration with Quality. • Lead cross-functional risk assessments to identify, evaluate, and mitigate operational, technical, and regulatory risks. • Monitor and communicate risk trends and key risk indicators to stakeholders. • Support commercial manufacturing operations by ensuring processes remain in a validated and controlled state. • Contribute to lifecycle management activities, including process improvements and continued process verification. • Collaborate with Regulatory, CMC, Quality, Supply Chain, Procurement, and Engineering to support commercialization and supply continuity. • Partner with internal teams and external CMOs to ensure alignment on validation and risk strategies. • Provide guidance for validation of processes, systems, facilities, and methods within the commercial organization. • Support deviation investigations, ensuring timely resolution and sustained compliance. • Contribute to authoring and reviewing regulatory filings and responses to health authorities. • Effectively communicate the scientific and commercial rationale for validation and risk management strategies. • Provide leadership for execution of process validation and comparability activities, ensuring data integrity and compliance. • Provide guidance on raw material qualification strategies to ensure supply reliability. • Support validation activities across internal and external manufacturing networks. • Communicate process validation performance and risk insights to key stakeholders. • Build strong working relationships and influence across a matrixed organization. • Contribute as a key member of the Global MSAT organization to enable successful commercialization. • Travel - 10-30% domestic and international travel required.

🎯 Requisitos

• Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with a minimum of 9+ years of relevant experience for Ph.D., 11+ years for M.S./M.A., or 14+ years for B.S./B.A. • Strong experience in biologics/vaccine manufacturing, including: • Process validation (PPQ/CPV) • MSAT, technical operations, or late-stage development • Technology transfer and commercialization • Experience in quality risk management (ICH Q9) and regulatory expectations • Demonstrated leadership in matrixed or cross-functional team environments • Ability to apply deep technical knowledge to develop strategies and drive execution • Strong problem-solving, organizational, and strategic planning skills • Excellent communication and stakeholder engagement skills • Ability to analyze data and align stakeholders with organizational strategy • Innovative and entrepreneurial mindset to drive continuous improvement • An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.

🏖️ Benefícios

• Comprehensive benefits • Equity component