Your role

• Define and drive the program CMC strategy aligned with program timelines, regulatory requirements, and business objectives
• Plan, coordinate, and execute all CMC activities from development through clinical supply to launch
• Ensure and coordinate CMC activities to be scientifically robust, compliant, and inspection-ready
• Project Management expert for highly visible interdisciplinary projects
• In a function as Workteam Lead CMC for our pipeline projects you cover all CMC / IMP (Investigational Medicinal Product) topics together with your team and different stakeholders
• You will lead and coordinate your team of SMEs and connect the dots, keep the overview also in unclear situations, and continuously challenge quality, timelines and budget
• Create oversights, project and budget plans, presentations
• Trigger and facilitate steering decisions, provide with the team solutions in difficult situations, escalate deviations from the plan
• Responsible for CMC project budget, strong collaboration with finance, manage budget in SAP
• Lead necessary Tec Transfers as responsible project manager. Inhabit a strategic and cross-functional key position for the technical project management and technology transfers of e.g. R&D
• Managing the oversight and coordination of different subprojects, aligning different project plans according to resources and priority
• Work with matrix responsibility for an interdisciplinary team including Business Leadership, Quality Assurance, Quality Control, Supply Chain, Finance, IT, Validation, Manufacturing, Regulatory Affairs, Engineering and CAPEX Management
• Communicate within the project team, internal and external stakeholders, facilitate adequate project documentation, report and follow-up on project milestones, coordinate financial and resource requirements, mitigate risks and align the project team on the project goal