Job Description
This is a rare opportunity to join a young and exciting clinical-stage biotechnology company that is focused on the discovery and development of novel therapies with the potential to fundamentally change the course of progressive debilitating diseases.
The company has experienced highly successful rapid growth in 2023.
The preferred candidate will bring passion energy and enthusiasm, as well as an entrepreneurial business-oriented mindset and a strong fit with the company's ethos.
The role of Drug Substance Manager is a permanent hybrid position based in Dublin HQ.
Key Responsibilities
The Drug Substance Manager is responsible for drug substance process development and manufacturing including:
1. Providing synthetic and manufacturing technology expertise and driving drug substance commercial process development
2. Ensuring prompt and coordinated supply of drug substance requirements
3. Working with the Analytical Services Manager to oversee the design development validation and transfer of suitable analytical methods and specifications related to APIs raw materials and intermediates for development and commercial manufacturing
4. Contributing to activities related to drug substance contractors and suppliers selection contracting management timelines and cost control
5. Designing and overseeing drug substance manufacturing site qualification and validation
6. Managing new product introductions and technical transfers
7. Interfacing with Quality to review vendor batch records deviation reports risk assessments and CAPAs and ensuring drug substance batches comply with specifications and processes
8. Interfacing with Quality to ensure vendors comply with GMP and Quality Agreements managing process and/or documentation changes in accordance with GMP regulations
9. Managing and following up with CMOs on a regular basis to ensure projects progress as expected and ensuring face-to-face contact with CMOs as necessary during critical phases
10. Acting as a