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.
About PAGE Pharmaceutical Academy for Global Excellence (P.A.G.E) is formed with the objective of setting up a world-class, cutting-edge institute to provide state-of-the-art training to fresh pharmacy graduates and existing employees of leading pharma companies promoting a culture of manufacturing and quality excellence. It is an initiative of the Indian Pharmaceutical Alliance (IPA) and is backed by 13 top Indian pharmaceutical companies, coming together with a shared commitment to nurturing the next generation of pharma talent.
Demonstrated understanding of pharmaceutical manufacturing, analytical testing, and quality assurance. managing CMC Regulatory submissions for small molecules/vaccines/biologics
Knowledge on cancers of the haemopoietic lineage. Collaborate closely with clinician colleagues and other investigators to explore novel therapeutic targets and strategies for cancer treatment.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Perform compliance and operational activities including QC check, DA checks and IND annual report writing. CMC contact for some countries and compliance, regulatory database entry and reports. Create CMC submission documentation such as folders structure, metadata forms, RA request forms and act as data stewards in the applicable Regulatory Information Management System.