Main Responsibilities & Tasks
Manage the transfer of manufacturing activities from an external manufacturer to Dreux site with all functions involved (Regulatory, EMO, Quality, and industrialisation team…) according to defined project plans and design and development process.
Ensure that all steps of the project plan are anticipated, planned, coordinated and followed-up to result in the most efficient way.
Consolidate inputs from all functions involved in the project and development process
Guaranty the overall consistency and the alignment with the objectives
Ensure product profile/ targeted product at required quality.
Monitor progress, detect, assess and address potential risks in constant interaction with project team and transparency with stakeholders:
Ensure consistent project planning and reporting
Alert/initiate appropriate warning with the team when risks are identified
Provide accurate risk analysis and design/propose mitigation plans
Ensure and coordinate corrective actions or alternative solutions according to project objectives, timelines, budget, in close interaction with stakeholders and functions and according to company standards
In case of external partnership or full external development, is responsible to ensure that all technical and scientific deliverables are properly managed.
Propose the development approach in terms of formulation, process and analytical development studies to be conducted.
Define CMO selection development criteria and participate to the selection of CMO for development and industrialisation purposes.
Is responsible for the realisation of the technical batches, the scientific assessment of the technical results and the communication of the results in appropriate documentation (technical report) within required timelines and according to regulatory requirement
Propose technical innovative solution for LCM product concept.
Participate to the write up of the technical section of regulatory dossier in accordance to applicable regulatory requirements (Pharmaceutical, Medical Device, Food Supplements)
Collaborate with different organization in the same environment activities.
Ensure proper coordination of a cross functional development team (formulation and analytical development activities, quality development, regulatory, industrialization team, EMO…)
Challenge when necessary the proposals from the different functions involved
Implement the appropriate communication within the development team to ensure transparency and ownership at all time.
Federate and facilitate the work of different functions according to project plan
Report development activities progress to the global project team.
Constantly maintain the appropriate degree of information towards stakeholders and any other possible interlocutor
Build and update dashboard and other reporting for the stakeholders
Alert appropriately when risks are identified
Address all questions concerning the project
Present team recommendations, corrective actions or alternative solutions
Design and implement the appropriate communication with the stakeholders to ensure transparency at all time.
Your profile :
Scientific background (Post graduate diploma, PhD, Pharmacist, Engineer degree + Master in Pharmaceutical Sciences) with ideally a Project management training and qualification.
Ideally more than 5 years’ experience in pharmaceutical Development Industry or consulting with preferably an analytical development expertise.
Project Management experience is required. In addition, an experience in a Function such as CMC, manufacturing or regulatory affairs would be considered as a plus.
Strong project planning and project management skills
Knowledge in Food supplement and Medical Device regulatory and quality standard
Has developed a comprehensive and broad overview of Product development process and the ability to understand the connections between all stages of the process from development to marketing
Ability to efficiently evaluate each stage of the project and to identify /predict bottlenecks and risks
Good understanding of different aspects and possible solutions in a broad range of problems such as chemical development and challenges during each phase, scale-up, life cycle management, registration etc…
Technical and/or behavioral competencies
Proven ability to scope, develop, and manage projects
Ability to create the conditions of efficient team work
Ability to lead and coordinate Cross functional projects
Ability to deal with and manage ambiguity
Strong facilitation and problem-solving skills
Interpersonal and facilitation skills necessary to drive alignment across the team and functions
Fluent English is mandatory
Tagged as: Development Project Manager
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