Senior Manager, Quality Assay Validation

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Sabin Vaccine Institute

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

Gegründet 1993

🏥 Gesundheitswesen

💼 Beratung

🍽️ Lebensmittel & Getränke

💰 €35.000.000 Grant im 2023-01

Healthcare • Consulting • Food & Beverage

Das Sabin Vaccine Institute widmet sich der Verbesserung der globalen Gesundheit, indem es den Zugang zu lebensrettenden Impfstoffen sicherstellt. Das Institut konzentriert sich auf die Forschung und Entwicklung neuer Impfstoffe gegen einige der dringendsten Krankheiten der Welt, darunter Cholera, HPV, Malaria, Marburg und Ebola. Durch innovative Programme und Partnerschaften zielt Sabin darauf ab, die Immunisierungskapazitäten und die Akzeptanz von Impfstoffen in den Gemeinschaften zu verbessern, um letztlich die Impfung für alle zugänglich zu machen, insbesondere für gefährdete Bevölkerungsgruppen.

Beschreibung

• Serve as the primary Quality representative for analytical method lifecycle management supporting vaccine development programs • Provide GMP quality oversight for analytical method qualification, validation, transfer, verification, implementation, comparability assessments, and lifecycle management activities • Partner closely with Analytical Development, Technical Operations, Regulatory Affairs, Supply Chain, and external laboratories • Support product disposition decisions through review of analytical data, investigations, and release testing results • Lead the quality function for assay validation, transfer, verification, comparability assessments, and lifecycle management • Provide quality oversight and approval of validation protocols, reports, transfer packages, analytical control strategies, specifications, and lifecycle documentation • Review analytical data packages, certificates of analysis, laboratory investigations, and release testing results • Review and approve deviations, investigations, CAPAs, change controls, OOS/OOT investigations, risk assessments, and analytical quality records • Support regulatory submissions, analytical sections of BLA/MAA filings, responses to health authority questions, and inspection readiness activities

🎯 Anforderungen

• Bachelor’s or advanced degree in scientific discipline • 9+ years of GMP Quality experience supporting analytical method validation, transfer, lifecycle management, and commercialization activities in vaccines, biologics, or pharmaceuticals • Strong understanding of analytical method qualification, validation, transfer, comparability assessments, specifications, stability testing, and lifecycle management • Demonstrated experience supporting analytical readiness for process validation, PPQ, regulatory submissions, and commercialization activities • Experience supporting health authority inspections, regulatory submissions, and responses to agency observations and questions • Working knowledge of 21 CFR Parts 210 and 211, ICH Q2, ICH Q10, FDA analytical validation guidance, and global regulatory expectations • Experience supporting analytical sections of BLA, MAA, or equivalent submissions preferred.

🏖️ Vorteile

• Medical, dental, and vision coverage • Flexible spending accounts • Flexible vacation and sick leave • Employer-paid life and disability insurance • 401(k) plan with employer matching • 11 federal holidays observed • End-of-year winter break