Experienced leader of TechOps, CMC, formulation development, clinical/commercial supply logistics, and injection device departments in small and large molecule formulation, scale-up process development and clinical/commercial product. Dosage forms developed and manufactured for clinical studies and validation/commercial launch include oral solids, sterile liquids / parenterals and topicals.Specialties: Small Molecule Formulation Development - IR and SRLarge Molecule Formulation Development - IR and SRTablet, Capsule, softgel, Injectable/parenteral dosage forms Fluid Bed, Pan Coating (film & enteric), controlled release, granulation, improve API solubilityRegulatory CMC sections - IND, NDA and IMPDLeading Cross Discipline Project TeamsProject ManagementBusiness Planning - Budgets, Timelines, proposalsCommercial Product Launch planning for combination productCommercial and Clinical labeling/packaging/distribution for global logistics supply chain.Controlled-release microspheres, Protein, Peptides, lyophilization, sustain-release, immediate release, polymer, granulation, fluid bed drying / coating, film coating, batch records, CRO, CMO, contract research organization, pharmaceutical development, PLGA, PFS, pre-filled syringe, cartridges, aseptic fill finish, analytical, TechOps, CMC, Technical Operations, BioTech, auto-injector, reusable injection pen, DHF, device
Listed skills include Formulation, Gmp, Pharmaceutical Industry, Biotechnology, and 43 others.