This organization is an Industry Leading Pharma focused on cutting-edge novel therapies in the Baltimore/Washington DC area. They are currently searching for a scientific leader to join their Leadership Team that will take on break through innovation to head up Drug Substance operations.
The Director of Drug Substance will be responsible for:
- overseeing small molecule chemical process development and manufacturing to commercial drug substance batch production
- Will maintain and file the technical documentation for external vendors to ensure they are compliant with the needs of the pipeline.
- Work in collaboration with internal team functions
- Actively support, author, review, and file (INDs, NDAs, CTAs, CTDs) for regulatory submissions.
The Process Chemistry AD must have the following qualifications:
- Ph.D. + 10 years of commercial industry experience
- Competent understanding of the CGMP regulations in Product Development Manufacturing and prior leadership experience.
- Thorough experience in Small Molecule chemical process development
- Detailed organizational and communication skills
- Highly competitive
- Generous Vacation Package