Senior Pharmaceutical Development Manager

at  Global Antibiotic RD Partnership GARDP

Are you looking for a change and eager to make a real impact on the global public health threat of antibiotic resistance? GARDP, a distinguished not-for-profit organization, is seeking a dynamic and proactive Senior Pharmaceutical Development Manager.
JOIN US and embark on a critical role as the Sr. Pharmaceutical Development Manager, steering the delivery of Chemistry, Manufacturing, and Control (CMC) activities for GARDP projects across all stages of R&D to access. With a focus on precision in quality, budget, and timelines, this role also actively contributes to the evolution of GARDP’s Pharmaceutical Development function.

REQUIREMENTS

Strategic CMC Leadership:

• Develop and execute strategies aligned with project and regulatory requirements.
• Lead regulatory CMC activities, ensuring technical data complies with relevant guidelines.
• Prepare project updates and reports for stakeholders, showcasing exceptional project management skills.

Operational Excellence:

• Identify, evaluate, and manage external CMC service providers.
• Monitor progress of CMC activities with pharmaceutical company partners and CMC service providers against milestones, as well as resolve technical, quality or resource issues efficiently.
• Drive progress, resolve issues, and maintain schedules, budgets, and risk mitigation plans.
• Organise quality agreements, audits, and performance improvements for external partners.

Quality Systems Development & Management:

• Contribute to the internal development and operation of the Pharmaceutical Quality System.
• Define best practices and guidelines for the Pharmaceutical Development department.
• Maintain awareness of applicable guidelines and regulations.

Additional Leadership Responsibilities:

• Actively contributes to strategic initiatives and organizational development of GARDP and the Pharmaceutical Development department.
• Supervises permanent staff, contractors and consultants as required.

• Actively contributes to strategic initiatives and organizational development of GARDP and the Pharmaceutical Development department.
• Supervises permanent staff, contractors and consultants as required