Senior Pharmaceutical Development Manager (UK, Spain, South Africa or India)

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!