• Design and develop formulations for topical, ophthalmic and injectable drug products which are robust, scalable and non-patent infringing to innovator following FDA Quality by Design (QbD) approach• Perform risk assessment for formulation/process development and establish CPPs, QTTPs and CQAs• Design and conduct experiments, develop manufacturing processes and optimize process variables• Oversee manufacturing scale up and cGMP production of Engineering or Exhibit/Clinical batches to support abbreviated new drug application (ANDA) submission

Professional Practice Laboratory:Responsibilities:Teaching preparation and dispensing of various dosage forms to Pharm. D. studentsGrading weekly worksheets and examinationsPreparing laboratories and attending pre-laboratory weekly meetingsClinical Pharmacogenomics, Clinical Pharmacokinetics, and Pharmaceutical Calculations:Responsibilities:Grading examinations

1) Developed generic solid oral controlled release pharmaceutical products, e.g., microspheres, tablets, and capsules, for small molecule drugs keeping in view regulatory compliance and intellectual property aspects. - Hands-on experience in solid dosage form unit operations such as particle size reduction and sizing, mixing, granulation, extrusion-spheronization, fluid bed processing, compression, coating, and encapsulation. - In-process testing for compression: weight, thickness, hardness and friability - In-process testing for coating: weight gain - Pilot bioequivalence studies to achieve in vitro-in vivo correlation (IVIVC) for submission in an ANDA2) Developed ready-to-use stable aqueous injection formulations of a poorly soluble drug (patent pending). - Micellar solubilization - Skilled in aseptic filling, packaging, and terminal sterilization - Stability testing3) Pre-formulation of the drug candidates4) Knowledge of cGMP and OSHA regulations