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Team Lead at Spectrum Talent Management
Views:271 Applications:27 Rec. Actions:Recruiter Actions:9
AGM/DGM - Technology Transfer - Pharma (10-20 yrs)
- 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.
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