Project Manager

Immacule Lifesciences; Solan; On-site; INR 2,500,000 - 3,800,000; Full time

Job summary

Immacule Lifesciences in India seeks a Senior Project Manager to lead end-to-end development, technology transfer, regulatory filings, validation, and launches for Injectable and Ophthalmic products.

You will drive cross-functional collaboration with R&D, Manufacturing, QA, Regulatory, and Commercial teams to meet milestones, ensure OTIF, and align with GMP and customer agreements.

Requires M. Pharm or MSc with PMP, 8–12 years' experience, and USFDA/regulated markets exposure.

Qualifications

• M. Pharm or MSc with PMP certification.
• 8–12 years of PM, technology transfer, product development or operations in injectable/ophthalmic formulations.
• Experience managing projects for USFDA and other regulated markets.

Responsibilities

• Lead project planning, execution, monitoring, and closure.
• Coordinate with R&D, Manufacturing, QA, Regulatory, Engineering, and Supply Chain.
• Drive technology transfer, scale-up, validation, and commercialization.
• Ensure OTIF (On-Time-In-Full) milestones above 95%.
• Identify risks, mitigate, and escalate issues to ensure timely execution.
• Provide progress updates to management and customers.
• Manage client projects and align with CMOs/CDMOs as needed.
• Ensure GMP compliance and adherence to regulatory commitments and customer agreements.
• Drive validation and commercialization targets aligned with business objectives.
• Escalate critical project/resource issues and drive resolution through cross-functional collaboration.

Skills

Project Management

Technology Transfer

Regulatory Affairs

Cross-Functional Leadership

Education

M. Pharm

Masters in PMP

Job description

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.