Senior Manager Project Management (Sterile)

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 updates to senior management and customers.
7. Manage external development, manufacturing, and technology transfer projects with partners, CMOs, and CDMOs.
8. Establish and implement standardized project management processes, governance, and reporting systems.
9. Ensure compliance with GMP requirements, regulatory commitments, quality standards, and customer agreements.
10. Drive annual filing, validation, and commercialization targets aligned with business objectives.
11. Build and develop a high-performing project management team and support organizational capability development.
12. Escalate critical project and resource issues in a timely manner and drive resolution through cross-functional collaboration.

Qualification & Experience

• B.Pharm / M.Pharm
• 8–12 years of experience in Project Management, Technology Transfer, Product Development, or Operations in Injectable/Ophthalmic formulations.
• Experience in managing projects for USFDA and other regulated markets.

Key Competencies

• Project Management
• Technology Transfer
• Stakeholder Management
• Risk Management
• Regulatory & GMP Compliance
• Leadership & Team Management
• Communication & Problem Solving