08 Sep
|
Immacule Lifesciences
|
Nalagarh
08 Sep
Immacule Lifesciences
Nalagarh
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
📌 Senior Project Director (Nalagarh)
🏢 Immacule Lifesciences
📍 Nalagarh