CMC Program Lead
New
Based in the United StatesFull-TimeLead
SalaryCompetitive base salary with performance-based bonuses
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Job Details
- Experience
- 10+ years of experience in pharmaceutical, biopharma, or radiopharmaceutical CMC development, including 5+ years in program or project management roles.
- Required Skills
- Project ManagementSAP
Requirements
- 10+ years of experience in pharmaceutical, biopharma, or radiopharmaceutical CMC development.
- 5+ years in program or project management roles.
- Strong understanding of CMC processes across drug development, manufacturing, and global regulatory requirements (FDA and other agencies).
- Proven experience working in highly matrixed, cross-functional environments with internal teams and external CDMOs/CMOs.
- Strong technical foundation in pharmaceutical or radiopharmaceutical development, supply chain, or manufacturing operations.
- Excellent leadership, communication, and stakeholder management skills, including experience presenting to senior leadership.
- Demonstrated ability to manage complex programs, timelines, budgets, and interdependencies in a global setting.
- Proficiency with project management and enterprise tools such as MS Project, SAP, Smartsheet, or equivalent systems.
- Strong analytical mindset with the ability to identify risks, drive solutions, and improve processes.
- A collaborative, adaptable, and results-driven approach with strong professional integrity.
Responsibilities
- Lead the planning, coordination, and execution of end-to-end CMC strategies for radiopharmaceutical programs from early clinical phases through pivotal studies and regulatory submissions (NDA/MAA/BLA).
- Serve as the CMC representative within global matrix teams, ensuring alignment across development, supply chain, quality, regulatory, and clinical functions.
- Drive integrated CMC program planning, including timelines, budgets, dashboards, and tracking of key deliverables and milestones.
- Identify, assess, and communicate program risks while developing mitigation strategies in collaboration with internal and external stakeholders.
- Lead and coordinate cross-functional CMC teams and facilitate effective decision-making through structured project management practices.
- Manage relationships with CDMOs/CMOs, including vendor selection, performance oversight, and alignment with program objectives.
- Ensure seamless communication of CMC status updates, KPIs, and forecasts to senior leadership and global stakeholders.
- Oversee documentation, meeting governance, and compliance with SOPs, GxP standards, and regulatory requirements.
- Support development-to-commercial transition planning and ensure continuity across product lifecycle stages.
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