M.Pharm / Ph.D in Pharmaceutics studied in Top Colleges; Test license application. Preparation of costing formula. Execution of Bio batches. Raw materials and Packing materials procurement. Pre-formulation studies. Master formula record and specification reviews. Formulation development and scale up. Stability Studies.
Responsible for release of the product by ensuring review of relevant audit trial of Manufacturing. Strong knowledge of cGMP, ICH guidelines, FDA regulations, and other relevant standards for biologics manufacturing.
Should have hands on experience in Water samples analysis, In-process Bioburden and BET analysis, MLT analysis of Raw material and packing material, Antibiotic assay by Microbial method.