General Manager Program Management

About the RoleA 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.ResponsibilitiesLead 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 InjectablesLyophilized InjectablesOphthalmicsPrefilled Syringes (PFS)CartridgesTarget Markets:USEuropeOther highly regulated markets QualificationsQualification: 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 SkillsProduct 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.