Senior Director, Integrated Product Development, PharmaLex
Research scientist with nearly 25 years drug development experience in managing Chemistry Manufacturing and Controls (CMC) operations for successful drug development programs.
- Characterization of Small molecules, recombinant proteins, oligonucleotide analogs
- Formulation development of small molecules and protein-based drug products
- Manufacturing optimization in organic and process chemistry
- Develop product formulation system for delivery recombinant protein therapeutics and biosimilars..
- Evaluate and recommend CMOs for the manufacture and supply of drug substance and drug product for non-clinical, clinical and commercial supply.
- Develops strategic technical programs within the CMC realm including product characterization, process development, analytical methods, formulation development, stability, and scale up processing
- Life Cycle Process Validation using QBD concepts.
- Synthesis and characterization of phospholipids polypeptide conjugates for use targeted diagnostic application.
- Optimization and production of lipid nanoparticles, microbubbles with the ability to anchor targeting agents.