• Perform extensive literature search on assigned projects.• Conduct preliminary studies involving products physical characterization and raw material pre-formulation screening.• Optimize prototype formulation by evaluating the Critical Process Parameters; Use QbD and DOE approach to investigate process performance, reliability and improvement opportunities.• Responsible for stability studies, and formulation optimizations for emulsions, suspensions, solutions, powder blends, and lyophilized drug products.• Assist with preparing and reviewing technical documents, including development plans, formulation justification documents, SOPs, validation protocols & reports and batch records. • Completion of tech transfer for 4 projects and development of 7 drug products.

• Perform Method Development/Evaluation/Optimization for raw materials, in-process products and finished products.• Operate, calibrate, maintain analysis equipment; HPLC, UPLC, GC, Karl Fisher Titer and online UV dissolution systems.• Efficient work with Empower software.• Conduct routine tests on stability samples according to stability schedule; compile data and graphs for documentation; review, understand and interpret analytical R&D data.• Participate in preparation and review of technical documentations including analytical method, method validation protocols and reports.• In-depth understanding of cGMP, ICH guideline, USP/NF compendial monograph and other regulatory guidelines.• Responsible for analytical support for ANDA fillings and submissions.