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You'll be the primary regulatory CMC voice on cross-functional matrix teams, covering everything from early clinical trial applications through to new marketing authorizations, post-approval changes, and full lifecycle management. That means you won't
Provide technical leadership and strategic guidance for upstream/downstream processing activities across the manufacturing network; Act as the primary point of contact for external partners, ensuring alignment with organizational goals; Lead harmonization
Design and execute experimental studies to develop and optimise purification processes for biologics; Evaluate and implement advanced chromatography and filtration technologies for intensified downstream processing; Develop scalable purification
Develop and lead clinical biomarker strategies across Ipsen's oncology and rare disease portfolio to support critical development and portfolio decisions. Define biomarker plans to support target engagement, pharmacodynamic and mechanistic understanding,
Lead oncology small molecule discovery programs from target identification and validation through PCC nomination. Integrate expertise across biology, medicinal chemistry, in vitro and in vivo pharmacology, DMPK, translational sciences, biomarkers,