Leading global Product Quality Teams of commercial and clinical products (The Product Quality Team consist of multi-functional representatives from Analytical, Process Developments, Quality Assurance, Quality Control, Quality Engineering, Complaints, Contract Manufacturing, and Regulatory CMC). Drive product quality strategies for analytical and process developments, stabilities, validations, technical transfers, cGMP compliance, and regulatory filings. Monitor and direct resolution of key product quality issues. Evaluate product impacts for changes and deviations. Accountable for product specifications, in-process specifications, annual product review, product quality risk assessment, and quality deliverables for regulatory CMC filings.

Led drug product team for developing commercial manufacturing process. Main activities included process scaling up, process characterization, clinical batch manufacturing, and supporting regulatory filings.

Built the Formulation department and the laboratories. Established CMC development and formulation research capabilities. Led the CMC developments of allergy vaccines. Supported CMC development of insulin pulmonary delivery product. Conducted drug delivery and formulation research for Allekine (a MCP-1 antagonist protein).

Stabilized decitabine intravenous formulation. Solubilized 9-nitro camptothecin for parenteral formulation using combinations of solvents and surfactants.

Developed controlled release formulations through spray drying of polymer latex. Modulated the release by selecting polymer latex (various Tg and core-shell structures), plasticizers, hydrophilic polymers, and processing conditions. Scaled up the spray drying to a pilot scale. Characterized spray dried microparticles by particle size, release rate, SEM, stability, surface properties, and bioefficacy.

Developed a micellar paclitaxel formulation using amphiphilic diblock copolymers of polylactide and methoxy polyethylene glycol (work resulted in 2 clinical trials). Conducted research on bioabsorbable paclitaxel surgical pastes using thermoreversible Pluronic F127, polylactide, lactic acid oligomer, and triblock copolymers of polylactide/polycaprolactone and polyethylene glycol for local treatment of cancer.Conducted research on controlled release formulations for vaccines and antibiotics.

Conducted research in water purification. Co-lectured in Industrial Chemistry. Supervised thesis research of one M.Sc. and two B.Sc. students.