AGM/DGM - Technology Transfer - Pharma

- Responsible for Technology Transfer from R&D to Site

- Responsible for Timely completion of scale up/pre-exhibit and exhibit batches at manufacturing for new drug application and Abbreviated New Drug Application.

- R&D Scale, Pilot scale to pivotal scale batch size for manufacturing of exhibit/filing batches.

- Execution of process validation batch manufacturing for approved ANDAs before commercialization.

- Responsible to undertake key studies associated with the product, formulation, manufacturing process and technical trouble shooting for smooth commercial manufacturing.

- Responsible for regulatory query response for process development work.

- Support to QA on technical for OOS, OOT and carry out changes to prevent failures in futures.