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api nda cmc ind dp📋 Description
- Lead Technical Operations across API, DP, analytical development, supply chain, and CMC.
- Ensure product supply from preclinical to commercialization.
- Provide strategic direction for technical development and manufacturing.
- Manage relationships with CMOs; ensure GMP compliance.
- Partner with Discovery, Clinical, Quality, Regulatory, and Commercial.
- Develop and manage annual budgets; forecast expenditures.
🎯 Requirements
- 20+ years in medicinal chemistry and analytical development; 10+ years biotech CMC leadership.
- Expert in small molecule synthesis, process development, and analytical development.
- Expert-level API/DP process development and scale-up.
- DOE, QbD, PAT; scale-up, formulation; GxP/ICH regulatory experience.
- Proven success advancing molecules from discovery to commercialization.
- Drafting Module 2/3 for INDs/IMPDs/NDAs/MAAs.
🎁 Benefits
- Competitive base salary plus incentive compensation.
- Medical, vision, and dental benefits; group life insurance.
- Flexible hybrid/remote work options.
- Equal opportunity employer; committed to inclusion.
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