Job Description
Position Summary
The Director of Active Pharmaceutical Ingredient (API) will be responsible for small molecule API Development for CMC projects including design of alternative syntheses, development of reproducible, robust manufacturing processes under cGMP. This individual will support all drug substance activities in contract development and manufacturing organizations (CDMOs). All interactions with CRO’s or CDMOs will be managed to ensure delivery of high-quality results and reports in time to meet regulatory requirements including GxPs. Additionally, he/she will be accountable for the delivery of proper documents for regulatory filings.
Essential Duties And Responsibilities
• Leads and manages multiple projects simultaneously, allocates resources and coordinates project activities to facilitate the achievements of major milestones of projects to ensure required deliveries on time;
• Interacts efficiently and effectively with other line functions incl...
The Director of Active Pharmaceutical Ingredient (API) will be responsible for small molecule API Development for CMC projects including design of alternative syntheses, development of reproducible, robust manufacturing processes under cGMP. This individual will support all drug substance activities in contract development and manufacturing organizations (CDMOs). All interactions with CRO’s or CDMOs will be managed to ensure delivery of high-quality results and reports in time to meet regulatory requirements including GxPs. Additionally, he/she will be accountable for the delivery of proper documents for regulatory filings.
Essential Duties And Responsibilities
• Leads and manages multiple projects simultaneously, allocates resources and coordinates project activities to facilitate the achievements of major milestones of projects to ensure required deliveries on time;
• Interacts efficiently and effectively with other line functions incl...