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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...Empfohlen
- ...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...Empfohlen
- ...This individual will perform activities supporting dispositioning product while ensuring compliance with Quality Assurance policies and... ...), product or program specific documents, deviation and change control review and approval, documenting batch review comments, and...Empfohlen
- ...Affinität zu computergestützten Laboranlagen 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...EmpfohlenSelbständige Tätigkeit
- ...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...EmpfohlenStellvertretung
- ...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...Empfohlen
- ...optimizing downstream purification steps—such as chromatography, virus inactivation, depth filtration, TFF, and filling—to ensure product quality, yield, and compliance with GMP standards. In charge of one or more defined DSP areas (e.g. gain, polishing or filling)...Empfohlen
- ...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,...Empfohlen