As part of Global Project & Portfolio Management (GPPM), the primary purpose of the CMC OPCM is to customize, plan and track the Research & Development (R&D) and Industrial Affairs (IA) CMC activities with their timelines, resources and costs reflecting the operational reality and aligned with the overall global project strategy.
Evolving in a global and international environment, the CMC OPCM is a member of the CMC Project Team covering scope from Research, to Preclinical and Clinical Development, and then Product launch on the market.
- For each assigned bio-therapeutic project (monoclonal antibody, gene therapy, enzyme replacement therapy…) and once agreed with the CMC Project Team actors, the CMC OPCM is the single accountable person for the accuracy of the plan entered and regularly updated in the planning tool. The CMC OPCM ensures that the CMC strategy is accurately reflected in terms of project logic with the timelines, resources and costs.
- In addition, the CMC OPCM provides workload and capacity analyses, and reporting to support the CMC Project Team and Managers in the CMC Functions. In particular, he/she develops scenarios to make recommendation on optimization of timelines, costs, resources, and to support decision for site re-allocation or outsourcing if any bottleneck.
- The CMC OPCM also analyzes the project deliverable timelines and critical path activities e.g., in support to CMC risk management assessment by the CMC Project Team.
- CMC Project Team members covering the whole CMC development in R&D and IA including Clinical and Commercial Supplies, Regulatory and Quality.
- Global Project Planning Managers embracing the project strategic planning.
- OPCMs working on other operational activities like preclinical and clinical development.
- CMC Functions Managers on local sites and also Finance, Controlling, Contract Management, etc…
- The whole community of CMC OPCMs working on all types of molecule modalities located in Frankfurt, Paris, Montpellier and Boston area USA
- Pharmacist / Engineer / MS / MBA
- Training and experience in Project Planning and Management
- Analytical, synthesis and reporting skills
- Excellent organizational skills, rigor, striving for results, high accuracy orientated
- Good knowledge in planning and management tools
- General knowledge on Project Management with ideally a first experience
- General knowledge on overall Pharmaceutical R&D Drug Development and good knowledge in CMC operational activities
- Strong communication skills and interpersonal relationship demonstrated
- Knowledge in Finance and budget.
- Excellent presentation skills (verbal and written)
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