The incumbent will be responsible for performing analytical method development and validations for USP/NF monographs and maintaining safety and GLP environment in the lab.
Masters degree in science area Chemistry, Pharmacy and a combination of skills and experience in the pharmaceutical or related industry, preferably working in Analytical Lab, Analytical reviewer role/Quality Assurance in API or formulations
MSc, M.Tech, M.Pharm. in relevant stream of Biological Sciences Or Ph.D with industry experience working in Analytical R&D. U.S. Pharmacopeial Convention
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.
Maintain smooth collaboration and works closely with key stakeholders across the globe to develop reference standards for biotechnology pharmaceutical products including proteins, peptides, heparins, antibiotics, and advanced therapies.
Support to reaction monitoring, scale up and final analysis of samples as per monograph, in-house procedures including method development if required. Prepare development reports for Synthetic Support projects. Involve in project acceptance. Execute projects per the approved test protocols if assigned.
This is a non-supervisory position to support development of Reference materials. The successful applicant in this role will work on projects including Analytical Method Development for in process samples for synthetic lab.
This is a non-supervisory position in Reference Standard Laboratory responsible for performing the required tests as part of the project and maintaining the GLP environment in the Laboratory. The incumbent will utilize his or her technical expertise, knowledge of pharmaceutical analysis in collaborative testing, efficient and effective laboratory operations.