CMC Development and Strategy Project Manager

Job Responsibilities .
Project support:
Oversee and drive project management activities by translating process development (PD) milestones (e.g., scale-up, process characterization, validation) into actionable CMC timelines. Manage comprehensive planning, timeline monitoring, and budget tracking for regulatory submissions. .
Project monitoring:
Track and report project status to internal and external stakeholders. Leverage your hands-on process development expertise to technically evaluate CMO/CDMO manufacturing activities, proactively identifying scale-up risks, yield variations, and equipment bottlenecks. .
Documentation management:
Manage, maintain, and critically review technical project documentation, specifically focusing on tech transfer protocols, process characterization reports, master batch records, SOPs, and meeting minutes. Facilitate the rapid collection of technical data from internal process engineers and external vendors. .
Stakeholder management:<...