About the Role A seasoned pharmaceutical CMO/CDMO program management professional with solid 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 environment.

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