Regional Program Manager
Rxilient Health Downtown Core Full-time
Rxilient Medical is seeking an experienced Regional Program Manager, CMC-focus. This role will serve as the regional subject matter expert (SME) in Chemistry, Manufacturing, and Controls (CMC), overseeing and driving complex programs related to manufacturing, technical transfer, and supply readiness.
This position requires strong collaboration with external partners including Pharmagend and other Contract Development and Manufacturing Organizations (CDMOs), as well as internal cross-functional stakeholders across regulatory, supply chain, quality, and commercial teams.The role is critical in ensuring seamless execution of CMC-related activities from product in-licensing through commercialization.
Specific accountabilities include:
- Lead and coordinate end-to-end CMC-related programs, particularly manufacturing scale-up, process validation, and technology transfer activities.
- Drive collaboration and alignment with Pharmagend and/or external CDMOs to ensure timely execution of development, manufacturing, and supply deliverables.
- Serve as the regional CMC subject matter expert, providing technical guidance and strategic input to internal and external stakeholders.
- Develop and maintain comprehensive program plans covering scope, timelines, milestones, budgets, risks, and resource requirements for CMC-related initiatives.
- Ensure effective cross-functional coordination between Regulatory Affairs, Quality, Supply Chain, Commercial, and external partners to support successful product registration and launch.
- Identify, assess, and proactively mitigate CMC-related risks, maintaining a structured risk and issue management framework.
- Monitor project progress and performance metrics, ensuring adherence to timelines, cost, quality, and regulatory requirements.
- Prepare and present regular program updates to senior leadership, highlighting key milestones, risks, mitigation plans, and strategic considerations.
Support process optimization and continuous improvement initiatives related to manufacturing oversight and tech transfer governance within the PMO framework.
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