Senior Manager, Quality Chemistry Manufacturing and Controls – Drug Product

🕒 il y a 5 jours

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Sabin Vaccine Institute

Site WebLinkedInTous les Emplois

51 - 200 employés

Fondée en 1993

🏥 Santé

💼 Conseil

🍽️ Alimentation et boissons

💰 €35 000 000 Grant en 2023-01

Healthcare • Consulting • Food & Beverage

L'Institut Sabin pour les Vaccins se consacre à l'amélioration de la santé mondiale en garantissant l'accès à des vaccins vitaux. L'institut se concentre sur la recherche et le développement de nouveaux vaccins pour certaines des maladies les plus urgentes dans le monde, y compris le choléra, le VPH, le paludisme, le Marburg, et l'Ebola. À travers des programmes et des partenariats innovants, Sabin vise à renforcer les capacités de vaccination et l'acceptation des vaccins au sein des communautés, s'efforçant finalement de rendre la vaccination accessible à tous, en particulier aux populations vulnérables.

Description

• 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)

🎯 Exigences

• 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

🏖️ Avantages

• 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