Senior Manager, Quality Chemistry Manufacturing and Controls – Drug Product

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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 primary Quality representative, providing cGMP oversight and risk-based quality decision-making across clinical and late-stage DP activities • Provide Quality oversight for clinical manufacturing, engineering runs, technology transfer, scale-up activities, process validation, and PPQ readiness • Participate in manufacturing readiness reviews and provide Quality approval for validation, media fills, PPQ execution, and commercial readiness activities • Review batch records, deviations, investigations, analytical and stability data, environmental monitoring results, and change controls to support product disposition decisions • Approve deviations, Corrective and Preventative Actions (CAPAs), change controls, risk assessments, and quality records supporting compliant operations • Provide Quality oversight of Contract Development Manufacturing Organizations (CDMOs) and contract laboratories, including supplier qualification, audits, inspection support, and CAPA implementation • Support preparation of quality documentation and responses associated with Biological License Application (BLA), Marketing Authorization Application (MAA), and other regulatory submissions • Support regulatory inspections, including the Food and Drug Administration (FDA) inspections, Bioresearch Monitoring (BIMO) inspections, and Pre-Approval Inspections (PAIs) • Lead the development, implementation, and continuous improvement of Sabin's Quality Management System, quality governance, and sponsor oversight processes to support the organization's transition to a fully compliant global Marketing Authorization Holder (MAH)

🎯 Anforderungen

• Bachelor’s or advanced degree in scientific discipline • 9+ years of Quality experience supporting biologics, vaccines, or pharmaceutical DP manufacturing • Proven experience supporting technology transfer, process validation, PPQ execution, manufacturing readiness, and commercial launch preparation • Demonstrated experience providing Quality oversight of aseptic manufacturing and fill-finish CDMOs • Experience supporting FDA inspections, BIMO inspections, and/or PAIs • Strong knowledge of 21 CFR Parts 210 and 211, Annex 1, ICH Q10, and global cGMP requirements applicable to sterile drug product manufacturing • Experience supporting BLA, MAA, or equivalent regulatory submissions preferred • Occasional travel required to support organizational alignment and business needs

🏖️ Vorteile

• medical, dental, and vision coverage • flexible spending accounts • flexible vacation and sick leave • employer-paid life and disability insurance • 11 federal holidays • end-of-year winter break • employer-matching 401(k) plan