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Your role: You will be responsible for the CMC Management of Marketed Products (Oncology/Immuno-oncology). The elaboration, execution and maintenance of an integrated CMC roadmap is to be ensured under your leadership by a cross-functional team that oversees CMC activities. This includes activities regarding raw materials, DS/DP, formulation, manufacturing process, analytical methods, packaging, regulatory dossier and ensuring compliance. Essential consolidation of input from Business Franchise, Manufacturing, Regulatory Affairs and Quality to define short, medium and long-term CMC activities will be key.
You ensure visibility to the CMC roadmap and major changes impacting CMC of Marketed Product. Additionally you communicate priorities and decisions concerning the CMC roadmap to relevant stakeholders. You will drive the alignment with and get approval from Global Product Team or to the relevant decision board.
The successful product Life Cycle Management (LCM) requires your proactive leadership not only to identify and prioritize opportunities for process improvements/efficiencies with and end-to-end view on the product but to enable the LCM execution in the organization – adequate budget/resource allocation, strict adherence to set timelines and providing technical advice.
This is a new role being established in the Biotech Manufacturing Operations, which offers the opportunities for development.
Who you are
- Master`s or Ph.D degree with minimum 7+ years of experience in biologics manufacturing, quality operations, regulatory affairs or CMC development - preferably broad experience in manufacturing and one additional area
- Substantial experience in leading international teams and project management
- Good understanding of manufacturing, quality control, GMP and regulatory requirements.
- Profound knowledge of the biotech business
What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!