CMC Project Manager/Planner Consultant
For one of its clients, a dynamic fast growing Biotech company , Benson & Winch is looking for a CMC Project Manager/Planner Consultant.
You are responsible for CMC (Chemistry, Manufacturing and Controls) project management incl. coordination, planning, execution, monitoring, controlling, budgeting for various drug development projects within the Planisware Enterprise Project and Portfolio management and reporting tool (EPPM). As CMC project manager/planner, you create high quality CMC plans and ensure effective communication and reporting of the project/portfolio status to stakeholders.
You translate with support of the CMC lead, the scientific strategy into a CMC project plan in the client Planning and Reporting tool (planisware) for one or more drug development programs/projects You create CMC project plans, set timelines and dependencies between CMC deliverables, define budget and resource needs (with resource manager), perform critical path analysis, taking into account cross-functional interdependencies in the overall development project plan You work with CMC project team members and ensure timely completion of CMC activities by continuously monitoring progress balancing scope, cost, timelines and risk
You identify and manage operational risks and issues with the team and ensure and implement contingency planning with team
You support and drive CMC project costing during Budget and Forecasting exercises You perform scenario simulations and advise on optimum development planning, as needed
You ensure project status (e.g. time, cost) communication, develop and run project plan reports and distribute to stakeholder pool
You develop, maintain and optimize CMC project plan templates in line with the client business processes, benchmarks and stakeholders You ensure the Planisware tool (EPPM) is optimally used to support the teams and you contribute to a sound project environment allowing the team to focus on project delivery You work with the CMC department staff, and Operations and Project Management staff, such as Cross-functional Project Management Leaders, System Owner, Operations, …
You have a Master degree
You have +3 years of experience in CMC development (Drug Substance, Drug Product, Method development and Analytics, Quality Operations) or in CMC project management for drug development projects/programs
You have a good knowledge of the drug development life cycle and the complex interaction between various functions (preclinical, clinical, CMC, regulatory etc.)
You have an advanced knowledge of information systems and business processes related to project planning, budgeting and reporting
Project management certification (PMP or equivalent) is a plus
Experience with Planisware and SAP is a plus
You have excellent analytical, planning and organizing skills
You have proven record of accomplishment of consensus building and conflict management in challenging situations, while continuously challenging the status quo
You have a customer focus
Stakeholder management has no secrets for you
This description matches your profile and expectations?