CMC Project Manager - Mechelen, BE
Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden) and in US, Boston.
We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happeners’.
We are looking for a CMC Project Manager/Planner.
Scope of the job
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 GLPG 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 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 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 GLPG 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 work with CMC project team members and ensure timely completion of CMC activities by continuously monitoring progress balancing scope, cost, timelines and risk
- You perform scenario simulations and advise on optimum development planning, as needed
Who are you ?
- 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
What’s in it for you?
You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.
We are Galapagos : together we can make it happen…!