About the Role
A seasoned pharmaceutical CMO/CDMO program management professional with strong sterile product expertise, proven US/EU market exposure, and a track record of managing complex client programs from development to commercial manufacturing. The candidate should combine technical understanding, commercial acumen, and customer-focused leadership to ensure reliable execution and long-term client partnerships. Responsibilities
• Lead end-to-end customer programs from project initiation and product development through technology transfer, regulatory submissions, and commercial manufacturing.
• Manage multiple client programs across sterile injectables and ophthalmic dosage forms, ensuring delivery against agreed scope, timelines, budgets, quality standards, and contractual commitments.
• Serve as the key interface between clients and internal teams, ensuring effective communication, progress reviews, escalation management, and customer satisfaction.
• Coordinate cross-functional activities across R&D;, Analytical Development, Regulatory Affairs, QA, QC, Manufacturing, Engineering, Supply Chain, and Business Development.
• Drive technology transfer, process scale-up, engineering batches, validation, and commercial manufacturing readiness.
• Oversee project planning, resource allocation, risk assessment, milestone tracking, and portfolio prioritization.
• Coordinate regulatory and technical documentation required for product development, submissions, and commercialization in the US and European markets.
• Manage external partners, vendors, and CDMOs, where applicable, to ensure timely execution and compliance with client requirements.
• Monitor program financials, project profitability, resource utilization,



and change requests in coordination with Finance and Business Development.
• Establish robust PMO governance, project dashboards, management reviews, and performance metrics to improve execution efficiency and on-time delivery.
• Identify and resolve technical, regulatory, operational, and supply chain bottlenecks impacting client commitments and product launches. Product Portfolio:
• Liquid Injectables
• Lyophilized Injectables
• Ophthalmics
• Prefilled Syringes (PFS)
• Cartridges Target Markets:
• US
• Europe
• Other highly regulated markets Qualifications
• Qualification: B.
Pharm./M.
Pharm., B.
Tech./M.
Tech. in Chemical Engineering, or a relevant scientific/technical discipline.
•

Experience:
18–20 years in the pharmaceutical industry, with substantial experience in program/project management within a CMO/CDMO workplace. Required Skills
• Product Expertise: Strong exposure to sterile injectables and/or ophthalmics; experience across liquid injectables, lyophilized products, PFS, and cartridges is highly preferred.
• US/EU Markets: Proven experience managing product development and commercialization programs for highly regulated markets, particularly the US and Europe.
• CDMO Operations: Demonstrated experience in client management, contract manufacturing programs, technology transfer, and commercial product launches.
• Regulatory & Quality: Sound understanding of US FDA requirements, EU GMP, cGMP, validation, and regulatory submission processes.
• Program Leadership: Proven ability to manage multiple complex programs, cross-functional teams, budgets, timelines, and competing priorities.
• Customer Management: Strong stakeholder management, communication, negotiation, and escalation-handling skills.

📌 General Manager Program Management (Nalagarh)
🏢 Immacule Lifesciences
📍 Nalagarh