1 year contract, full time
Program Manager Drug Substance (DS) development and industrialization
The project involves a complex development program with the aim to deliver a robust manufacturing process ready for commercial manufacture whilst in addition to timely delivery of DS for a number of development and clinical trials. It includes activities on 6 different sites, all located in the EU.
The objective of the mission is to ensure appropriate coordination between all development activities to meet the product demands during the development phase and to build the necessary documentation to support the NDA submission and securing the launch of the product on the market.
o Global program management including:
§ Activity timelines definition – Project Plan/Gantt Chart
• Coordination of process chemistry and analytical activities over multiple sites
• Oversight of multiple production campaigns for clinical trials
• Identification of key milestones and critical paths
§ Risk management/mitigation
• Mapping of progress and project plan update
• Coordination with project leaders (technical leads)
• Update to matrix management
Key attributes for the individual would be;
• High level of expertise/experience in Pharmaceutical Development in particular CMC activities
• Extensive experience as a program/project manager (as opposed to technical manager)
• Track record of successful delivery to ambitious timelines within the Pharm Environment
This would be full time for a 1 year fixed term, starting as soon as feasible. Minimum 3-4 days a week on site near Brussels with occasional travel within EU. Good communication skills in English is mandatory, French would also be of benefit.