The development and manufacture of a new API involves many challenges:
- Developing a robust and effective manufacturing process
- Managing seamlessly the scale-up, process validation and manufacturing
- Meeting quality and regulatory objectives
- Respecting timelines to reach your milestones in a cost-effective way
Novasep assigns an experienced Project Manager to each project to meet these challenges, acting as the primary on-site contact for customers and ensuring effective communication & action follow-up at all times.
Our CDMO Project Management approach
Novasep has a well-established Project Management organization, with dedicated Project Managers on each site.
By setting up the appropriate organization, then planning and coordinating all the activities, the Project Manager:
- ensures the achievement of the project objectives (quality, costs, deadlines, customer satisfaction) and monitors project status to make sure everything stays on track
- anticipates changes and risks and identifies appropriate actions
- coordinates all functions involved in the project (process development, manufacturing, quality control, regulatory affairs…) and acts as the primary customer interface
Our Project Managers competencies are regularly refined with professional trainings within the Project Management College of Novasep University.
This college was also established to spread best practices: our Project Managers are delivering trainings on fundamental Project Management methodologies and techniques to colleagues across the organisation.
From RFP to delivery
Novasep Project Management integrates all project activities and processes, from initial assessment and planning, to final delivery & close-out:
Project planning
- Understanding of the project objectives and customer requirements
- Development of the solution according to the customer’s needs
- Evaluation of resources required and definition of scope, timelines and costs
- Preparation of a proposal and review with the customer
Project initiation
- Team assignment: Project Manager and dedicated experts (Process Development, Analytical Development, Quality Control, Quality Assurance, Industrialisation / Production, HSE…)
- Review of project objectives, planning and scope with the customer
- Alignment of the project governance with the customer’s needs & expectations
Project execution
- Management of the communication of the project (including regular customer calls & reports)
- Leadership of the project through each technical phase
- Active risk and change management
- Monitoring and controling of the project status (quality, quantity, time and costs)
- Close collaboration and alignment with the customer at all stages
Project close-out
- Formal wrap-up of the project with the customer
- Extraction of lessons learned and identification of improvement opportunities
- Review of detailed customer feedback
Meet one of our Project Manager speaking about her missions and responsabilities:
What our customers say about our Project Management
“Professional Project Management, clear communication, pleasure working together on this project.”
US Big Pharma
“It was a pleasure working with Novasep. This project (tech transfer, PD/AD, GMP manufacture) operated under very difficult circumstances (COVID, changing deliverables, etc.) yet was still successful, by all metrics (quality, quantity, budget, etc.), very much appreciated.”
US Big Pharma
“Project Management was very effective, especially in navigating around several issues that arose during the campaign.”
US Biopharma company
“Project Management was also very good: good communication and on time for the follow-up/documentation.”
EU Biotech
