This position will be involved with chemical process development and scale-up projects, work with external contract service providers and participate in multidisciplinary project teams. Working on projects from discovery through commercial product supply.
- Key member of the CMC project team to ensure supplies to support research, non-clinical, and clinical studies
- Technical support to manage API process development and manufacturing activities
- Authoring detailed technical and manufacturing reports to document the process development
- Technology transfers between manufacturing sites
- Manage process characterization studies and critical parameter selection for late stage programs
- Ensure GMP manufacturing performed at CROs and CMOs is in compliance
- Authoring and reviewing documents related to GMP operations and Regulatory submissions
- MS degree or Ph.D. in chemistry, chemical engineering or related field
- 10+ years of proven experience in pharmaceutical small molecule synthesis, process development, scale-up and commercial scale manufacturing.
- Experience working in a virtual pharmaceutical development environment managing CMO activities
- Hands-on, collaborative and cross-functional leader
- Exceptional personal management and organization skills
- Working knowledge of CFR/ICH/GMP etc.
- Ability for occasional to travel to CMO sites