About the Role
To lead and govern operational and strategic manufacturing process technology transfer of sterile dosage formulations (PFS, Cartridges, Vials, Ophthalmic) from DDRL to Receiving Units (RUs) and CMOs. Ensure seamless scale-up, exhibit execution, and commercial validation adhering to project timelines, budget, cGMP, GDP, and global quality standards. Drive team performance, cross-functional alignment, and technical risk mitigation across all sterile transfer projects.

Responsibilities
1. Assessment & Feasibility Oversight
• Lead assessment, batch planning, equipment capability evaluation, and chain matching across RUs and CMOs.
• Ensure site readiness, including test licenses, cleaning validations, SAP codes, and RM/PPM vendor qualifications.
• Ensure RM/PPM procurement, change controls, and assessment batch documentation (BMRs, Sampling Plans) as applicable.
• Evaluate Assessment Batch Reports and determine exhibit/submission batch strategies.
• Undertake preparation of Quality Risk Assessments (QRA) and Failure Mode, Effects, and Criticality Analysis (FME(C)A)



as systematic, proactive methodologies to identify, evaluate, and prioritize potential risks or failures in processes, designs, or systems before they cause harm or operational breakdown at RUs or CMOs.

2. Exhibit & Regulatory Submission Governance
• Drive end-to-end strategy for submission/exhibit batches across internal sites and CMOs.
• Review regulatory requirements and equipment constraints to approve target batch sizes and process parameters.
• Troubleshoot concerns encountered in assessment and / or exhibit manufacturing, OOS, and stability trends.
• Review Process Validation Reports, Hold Time Study Reports, and propose commercial batch size proposals based on sales forecasts.

3. Commercial Launch Validation & Scale-Up
• Review commercial validation protocols (PPQP) and BMRs aligned with RA packages and exhibit data.
• Provide technical direction during initial commercial validation b

📌 Manager - Technology Transfer ( Sterile) (Mumbai)
🏢 USV Private
📍 Mumbai