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.
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.