Constance, Baden-Württemberg, Germany
o Senior Project Manager / Program Manager / Business Manager o 20+ years of project management experience in product development, manufacturing, launch and life cycle management of biopharmaceuticals and vaccines o Able to lead cross-functional international teams in a global matrix organization o Holistic understanding of pharmaceutical product development, manufacturing and supply chain management o Strong background in GLP/GMP/GDP and regulatory guidelines o Experienced in analysing stakeholder networks and optimizing organizational efficiency by designing improved business processes and governance frameworks o pragmatic, realistic, reliable, perseverant, supportive
• Responsible for developing and implementing project management best practices, methodologies, tools, and the governance frameworks across the R+D organization • Providing guidance to program and project managers, collaborating with cross-functional teams and line functions, and driving continuous improvement in project delivery, quality, and performance across the portfolio of discovery and development projects
• Leading a company-wide change initiative for implementation of a program team model fostering an end-to-end approach to drug discovery and development • Establishing fit-for-purpose business processes to improve the overall performance of the company’s product development organization
• Initially, acting as Program Manager and leading the team of project managers driving the CureVac - GSK collaboration program consisting of five projects targeting various infectious diseases • Subsequently, leading the Drug Development Project Management department with project managers assigned to drug development projects • Driving the consistent implementation of project management standards applied to drug development projects
• Leading the Commercial Manufacturing Readiness program for the Dengue vaccine covering requirements of manufacturing and supply chain, IT, finance and tax, quality and regulatory affairs • Designing/guiding the implementation of the end-to-end supply chain for product commercialisation • Strategizing/aligning cross functionally the Life Cycle Management projects’ portfolio, and facilitate implementation of respective projects • Providing input to license agreements, commercial manufacturing agreements, and related quality agreements
• Accountable for the global end-to-end supply chain strategy of a family of antihypertensive products • Driving risk assessments and risk mitigation strategies; conduct cost-benefit analyses • Developing short & long term supply strategies considering internal or external manufacturing opportunities • Coordinating transfer of manufacturing processes (drug product, packaging) to new sites • Managing the relationships to contract manufacturing organizations and analytical service providers • Setting up initial supply chains incl. financial, managerial, physical and release flows • Ensuring in-time product supply for product launches globally • Providing input to business development opportunities for (bio)pharmaceuticals
• Planning, budgeting and coordinating all CMC-activities for development and production of biopharmaceuticals (incl. analytical methods, setup of stability studies, process validation, etc.) to be used by clients in clinical trials or for initial market supply, taking respective GMP- and applicable regulatory guidelines into account • Coordinating CMC-data and input to CTA-/IND-, or CTD-dossier sections • Implementing and coordinating a network of external service partners
• Managing the sourcing of specific/customized materials (APIs, etc.) and analytical services • Reviewing/issuing sections of commercial supply agreements incl. related quality agreements • Guiding/supporting the commercial manufacturing setup/the regulatory submission for licensing of a biopharmaceutical and a hemostatic collagen surgical patch
see above