Senior Manager
1 month ago
AGM - Technology Transfer (Formulation)
Job Summary:We are seeking a highly experienced and skilled professional to lead our technology transfer activities for solid oral dosage forms in regulated markets. The successful candidate will be responsible for planning and executing scale-up and exhibit batches, managing technical service areas, and coordinating with cross-functional teams to meet aggressive timelines for regulatory submissions.
Key Responsibilities:- Plan and execute scale-up and exhibit batches of solid oral dosage forms for regulated markets (US, EU, ROW, and Canada)
- Manage and maintain technical service areas (pilot batch areas)
- Review and approve documents relevant to scale-up and exhibit batches execution, including BMR, BPR, protocols, scale-up reports, and exhibit batches reports
- Coordinate with cross-functional teams (site manufacturing, R&D, RA, PDC, Supply Chain) to meet aggressive timelines for regulatory submissions
- Review, approve, and implement change control proposals, deviations, and CAPAs for scale-up and exhibit batches
- Evaluate and respond to deficiencies of drug products by regulatory agencies
- Support production departments for validation batches and troubleshooting of commercial batches
- Perform job responsibilities in compliance with cGMP, SOPs, and all other regulatory agency requirements
- 15-20 years of experience in technology transfer activities for solid oral dosage forms in regulated markets
- Experience in managing teams of 15-20 scientists, documentation officers, and technicians
- B.Pharma/M.Pharma qualification
Kandivali, Mumbai
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