Job Purpose
To manage end-to-end project completion for Injectable and Ophthalmic products, ensuring timely development, technology transfer, regulatory filings, validation, and commercial launches through effective cross-functional coordination to meet client expectations.
Key Responsibilities
- Lead project planning, execution, monitoring, closure, and source change management activities.
- Coordinate with R&D, Manufacturing, QA, QC, Regulatory Affairs, Engineering, Supply Chain, and Commercial teams for successful project delivery.
- Drive technology transfer, scale-up, validation, and commercialization of products for US and other regulated markets.
- Ensure achievement of project milestones and maintain OTIF (On-Time-In-Full) performance above 95%.
- Monitor project timelines, identify risks, and implement mitigation plans to ensure timely execution.
- Conduct project review meetings and provide timely progress updates to management and customers.
- Manage client projects and meeting expectations to partner them as a CMOs, and CDMOs.
- Ensure compliance with GMP requirements, regulatory commitments, quality standards, and customer agreements.
- Drive validation, and commercialization targets aligned with business objectives.
- Escalate critical project and resource issues in a timely manner and drive resolution through cross-functional collaboration.
Qualification & Experience
- M. Pharm / Masters in PMP
- 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
