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- ...oversight of deviations, investigations, risk assessments, change controls, and CAPAs. The Senior Manager will conduct detailed reviews of... ...to detail. Knowledge in both clinical and commercial product desired. Excellent verbal, written, and interpersonal communication...Suggéré
- ...through PPQ and ongoing commercial production, onsite at contract... ...reaction kinetics, in-process controls, and common side reactions/impurities... ..., process capability, control charts/CPV trending, and clear... ...experience with biochemical reaction, product recovery, and purification...Suggéré
- ...criteria, and support deviation investigations. Act as the Validation Subject Matter Expert (SME) for non-conformities and change controls. Prepare and support Performance Qualification (PQ) studies. Represent Validation in customer meetings, inspections, and...SuggéréTemporaire
- ...Management interner und externer Kundenbeziehungen Arxada bietet erstklassige Lösungen in zwei klar abgegrenzten Bereichen: Microbial Control Solutions (MCS) konzentriert sich auf Bedrohungen durch Mikroorganismen für Mensch und Umwelt. Dieser Bereich umfasst fünf...SuggéréRemplaçant
- ...risks and mitigating actions and communicate/escalate accordingly to ensure clarity of deliverables and timing to achieve overall product/project plan and corporate goals/objectives. Lead CMC cross-functional coordination meetings, including scheduling and facilitating...Suggéré
- ...demonstrating integrity, accountability, equality and clarity across communications and decision making. Summary: As Vaxcyte’s products progress toward late-stage development and commercialization, the Manufacturing organization requires robust digital tools,...Suggéré