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.
Serve as the subject matter expert for feasibility-related practices and provide strategic input during protocol development and country/site selection.
The incumbent is responsible for providing support for the development of USP documentary standards and reference standards for biological products such as peptides, Oligonucleotides, protein, carbohydrates, Complex Biologics, Vaccines, Antibiotics, and advanced therapies.
Oversee the timely order and shipment of comparative samples from various suppliers to partners and Clinical Research Centres (CROs) globally to assist in bioequivalence studies.