CDMO Project Lead

Experience : 12 to 16 years of experience in CDMO industry.

Qualification : M.Sc. with any chemistry / B. Pharma / M. Pharm background.

Work Location : Honour R&D (CDMO), Bonthapally, Hyderabad

Key Responsibilities :

• Develop comprehensive project plans, including detailed timelines, milestones, and resource allocation. Drive project teams from initiation through planning, execution, monitoring, control, and closeout phases.
• Ensure strict adherence to all relevant global and local regulatory, quality and safety guidelines, such as FDA, EMA, and Good Manufacturing Practices (GMP).
• Proactively identify, assess, and mitigate potential project risks, developing contingency plans to address unforeseen issues, delays, or safety concerns.
• Prepare detailed project budgets and financial forecasts, monitor expenditures, and optimize resource utilization to ensure the project remains within financial constraints.
• Ensure all customer deliverables and expectations, as captured in the Project Charter, are met in full and on time, and proficiently communicate with regularity.
• Track, maintain, and report On-time In Full (OTIF) performance for all CDMO projects
• Lead and coordinate cross-functional teams, including but not limited to R&D, Quality, Analytical, Production, and Regulatory personnel, ensuring alignment and clear communication across all departments.
• Serve as the primary point of contact for internal and external stakeholders, including customers. senior management, investors, and third-party vendors. Provide regular, detailed reports on project status, risks, and performance metrics.
• Conduct regular reviews to ensure all project deliverables meet the required standards and client expectations.
• Maintain thorough project documentation, including protocols, reports, and lessons learned, for governance, compliance, and future reference.