Sterile Product Development Program Lead

Job Purpose

To manage end-to-end project execution for Injectable and Ophthalmic products, ensuring timely development, technology transfer, regulatory filings, validation, and commercial launches through effective cross-functional coordination.

Key Responsibilities

1. Lead project planning, execution, monitoring, closure, and change management activities.
2. Coordinate with R&D, Manufacturing, QA, QC, Regulatory Affairs, Engineering, Supply Chain, and Commercial teams for successful project delivery.
3. Drive technology transfer, scale-up, validation, and commercialization of products for US and other regulated markets.
4. Ensure achievement of project milestones and maintain OTIF (On-Time-In-Full) performance above 95%.
5. Monitor project timelines, identify risks, and implement mitigation plans to ensure timely execution.
6. Conduct project review meetings and provide regular progress upda...