TPD Project Leader

Reporting to the Manager, this Project Leader will be assigned the following functions:

• Management and development of projects within the Pilot Plant scope, including process scale-up study phases, as well as validation thereof for regulatory purposes. The projects under development under their responsibility will be mainly solid oral forms.
• Collaborate with the rest of the project team personnel (Pharmaceutical Development, Analytical Development, Quality Assurance, Registrations,...) in the development phases involving transfer, ensuring the proper transfer of know-how.
• Take technical responsibility for the commercial launch of the developed product once the medicine is already approved, preparing the precise documentation that supports the transfers of the projects under development.
• Support the development of the processes necessary for project execution: qualification of facilities and equipment, systems, processes, stability studies, preformulation, formulation, etc.
• Participate in scale-up process transfers both from the galenic development laboratory to the Pilot Plant and from the Pilot Plant to the industrial plant.
• Propose improvements in the areas and/or activities under their responsibility.
• Coordinate diligently and efficiently with the rest of the areas and departments involved in project development, especially: Pharmaceutical Development, Analytical Development, Quality Assurance, Project Management, Program Management, and Clinical.
• Organize and direct efficiently the resources assigned to projects to achieve the objectives
• Collaborate on other Pilot Plant projects when requested
• Know and comply with cGMP regulations as well as OSH, hygiene, environment, and social responsibility regulations.

• Degree in Pharmacy, Chemical Sciences. A Postgraduate degree or Master's in the pharmaceutical R&D field is valued
• English - advanced level
• 3 to 5 years as an R&D Project Technician (pharmaceutical development and scale-up), with experience in injectables. Experience in a University Galenic Laboratory and/or Pilot Plant in the pharmaceutical sector is valued
• We are looking for people with organizational and time management skills, good communication skills, and the capacity for influence, analysis, and attention to detail.