Master degree in Pharmaceutical Sciences or Pharmaceutical Technology or its U.S. Equivalency and two 2 years experience in Pharmaceutical Research and Product Development. Employer is willing to accept any suitable combination of education, training, or experience. Experience must include Formulation Research and Product Development activities of Generic Specialty Formulations of Immediate release tablets, Extended release tablets, oral solutions, suspensions, and Capsules; Prepare chemistrybr manufacturing control CMC documents PDRQOS etc. for regulatory submissions; formulation development of different dosage form for ANDA submission; experience in preparation of SOPs and in handling product specific queries from USFDA and other regulatory agencies , preparation of Technical and Regulatory documents in relation to compliance for filing in regulatory agencies; Preparation of the drug substanceinprocessbr finished productstability specifications its justifications as per US FDAICH guidelines , experience in development successful technology transfer at commercial scale of multiparticulate drug delivery systems Pellets Mini Tablets; experience with formulation development of powder for oral suspensions successful technology transfer at commercial scale and involved in execution of scale up, exhibit and validation batches, Hands on experience of equipment handling like high shear granulator, hot melt extruder, fluid bed processor dryergranulator Wurster coater.
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