USP

Engage in project planning, execution, method development and validation of projects according to set standards as USP general chapters, guidelines, SOPs and protocols. Apply technical and scientific expertise in analytical method development and validation of Small molecule projects.

Successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders.

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 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.

Responsible for managing the development of PAIs by working in collaboration with internal and external stakeholders, partners as necessary

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.