What are the responsibilities and job description for the Process Development CMC Leader position at AL Solutions?
Position Overview :
We are seeking a Process Development CMC Leader to drive Chemistry, Manufacturing, and Controls (CMC) strategy and execution for client projects. This individual will oversee process development, technology transfer, and scale-up activities , ensuring alignment with regulatory expectations and industry best practices. The role requires close collaboration with cross-functional teams, clients, and regulatory authorities to facilitate the successful development and commercialization of biopharmaceutical products.
Key Responsibilities :
- CMC Strategy & Leadership : Develop and implement CMC strategies for client programs, ensuring seamless integration of process development, analytical development, and manufacturing activities .
- Process Development Oversight : Lead upstream and downstream process development for biologics, cell and gene therapies, or small molecules, optimizing scalability and manufacturability.
- Technology Transfer & Scale-Up : Manage tech transfer from R&D to GMP manufacturing , collaborating with internal and external teams to ensure successful execution.
- Regulatory Compliance & Documentation : Author and review CMC sections of regulatory submissions (IND, BLA, NDA, MAA, etc.) , ensuring compliance with FDA, EMA, and ICH guidelines .
- Cross-Functional Collaboration : Work closely with QA, QC, Manufacturing, Regulatory Affairs, and clients to align on CMC strategies and execution.
- Risk Management : Identify potential risks in process development and manufacturing and implement mitigation strategies.
- Innovation & Continuous Improvement : Stay updated on industry trends, emerging technologies, and regulatory changes , driving innovation in process development and manufacturing .
Qualifications & Experience :
