Senior Pharmaceutical Development Manager (Remote)

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

Who you are:

• Fluent in English, other languages an asset
• Bachelor’s degree in chemistry, chemical engineering or pharmacy
• Post-graduate qualification (Master’s or PhD) in an organic chemistry or process chemistry discipline is preferred
• Minimum 6 years in API, formulation, regulatory CMC, or CMC management
• 4 years in a senior R&D role is preferred
• Demonstrated teamwork and CRO/CDMO management experience

Expertise that Sets You Apart:

• API and drug product technology transfer, scale-up, registration and commercial manufacturing
• Go-to subject matter expert for development, manufacture, validation, optimization and due diligence of active pharmaceutical ingredients and processes
• Product life-cycle management (e.g. post-approval changes, COGS reduction, line extensions/reformulation, pediatric formulations)
• Manufacturing of beta-lactam containing antibiotics
• Manufacturing of sterile injectable products

Location and Travel:

• Location in Spain, the United Kingdom, South Africa or India is flexible, but candidates must be willing and able to undertake regular business travel in India/South Asia (up to four days per month) and to the Geneva office when required

To Apply:

• Please submit your application using the online form
• Accepting applications until 31.10.2024
• All applications will be reviewed after closing date

APPLY NOW to be part of GARDP’s mission, where your skills contribute to combating drug-resistant infections and advancing global health solutions!