Management:
- Management of outsourced API and formulation development projects.
- Management of manufacturing tasks to support clinical / preclinical activities.
- Technical leadership to develop chemical assets
- Management of vendors and associated costs within budgets.
- Specifications development for API and drug products in a phase-appropriate manner.
- Chemical development support to cross functional drug development areas.
Technical:
- Review and manage syntheses of small molecule drugs. Optimize scale up, processing and costs.
- Chiral chemistry.
- Chemical, classical resolution and enzymatic synthesis.
- Support development programs through metabolite and radiolabeled molecule synthesis.
- Chiral chemistry.
- Formulation development to fit specific delivery needs. Manage chemical and physical properties of dosage form.
- Develop analytical development strategy with stability studies and other critical analytical techniques. Strong HPLC methods development background.
- Provide GMP review and guidance during the scale up and manufacture of the drug substance and drug product. Complemented by strong QC and QA background.
- Manage aseptic drug product manufacturing.
- Experienced in critical development properties.
- Experienced in limited solubility APIs.
- Polymorphism identification and screening.
- Metabolites – Chemical and enzymatic preparation, P450 substrate / inhibition.
- Writing of the Chemical and Manufacturing Controls (CMC) section for IND/NDA submissions.
