A solid track record in drug product development and cGMP manufacturing including conception, formulations, technology transfer, process scale-up, and commercialization of solid, liquid and parenteral dosage forms.
Reverse engineering of brand products for the development of generic formulations.
Hand on experience in optimization of poorly soluble drug formulation and process variables using QbD/ DoE principles.
A self motivated person with keen abilities and in depth understanding of Formulation development.
Familiar with NDDS, VAG, F2F Para IV, CMC, IND, NDA, ANDA, 505(b)(2) NDA, Clinical studies, BA-BE studies. cGMP regulations of UK-MHRA, US-FDA, TGA-Australia, PIC/S.
Assist in the ...