21 Aug
|
Immacule Lifesciences
|
Shimla
21 Aug
Immacule Lifesciences
Shimla
Job Description
Job Purpose
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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.
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Key Responsibilities
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1. Lead project planning, execution, monitoring, closure, and source change management activities.
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2. Coordinate with R&D;, Manufacturing, QA, QC, Regulatory Affairs, Engineering, Supply Chain, and Commercial teams for successful project delivery.
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3. Drive technology transfer, scale-up, validation, and commercialization of products for US and other regulated markets.
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4. Ensure achievement of project milestones and maintain OTIF (On-Time-In-Full) performance above 95%.
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5. Monitor project timelines, identify risks, and implement mitigation plans to ensure timely execution.
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6. Conduct project review meetings and provide timely progress updates to management and customers.
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7.
Manage client projects and meeting expectations to partner them as a CMOs, and CDMOs.
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8. Ensure compliance with GMP requirements, regulatory commitments, quality standards, and customer agreements.
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9. Drive validation, and commercialization targets aligned with business objectives.
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10. Escalate critical project and resource issues in a timely manner and drive resolution through cross-functional collaboration.
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Qualification & Experience
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- M. Pharm / Masters in PMP
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- 8–12 years of experience in Project Management, Technology Transfer, Product Development, or Operations in Injectable/Ophthalmic formulations.
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- Experience in managing projects for USFDA and other regulated markets.
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Key Competencies
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- Project Management
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- Technology Transfer
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- Stakeholder Management
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- Risk Management
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- Regulatory & GMP Compliance
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- Leadership & Team Management
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- Communication & Problem Solving
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📌 Manager Project Management (Shimla)
🏢 Immacule Lifesciences
📍 Shimla