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!
