Project Manager

Immacule Lifesciences; Himachal Pradesh; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Immacule Lifesciences in India seeks an experienced Project Manager to lead end-to-end development, technology transfer, and regulatory filings for Injectable and Ophthalmic products. You will coordinate R&D, Manufacturing, QA, Regulatory Affairs, Engineering, and Supply Chain to ensure on-time, compliant product launches in US and other regulated markets.

The role requires deep expertise in GMP, regulatory submission processes, and cross-functional leadership to meet client expectations and

Qualifications

• 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.

Responsibilities

• Lead project planning, execution, monitoring, closure, and source change management activities.
• Coordinate with R&D, Manufacturing, QA, 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.

Skills

Project Management

Tech Transfer

Stakeholder Management

Risk Management

Regulatory/GMP Compliance

Leadership

Communication

Problem Solving

Education

M. Pharm

PMP Certification

Job description

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