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He/She supports BeOne Clinical and Medical assets by successfully developing a late-phase/post-approval clinical development strategy. He/She will partner with pre-approval clinical development Program leads and support the execution of medical affairs
Design and execute formulation strategies for biosimilar products including monoclonal antibodies, fusion proteins, and other biologics. Plan and oversee pre-formulation studies, stability testing, and compatibility assessments. Lead and mentor a team of
A strategic role that drives enhanced compliance throughout the PV domain to support the obligation of the Marketing Authorization Holders and appointed QPPV, to maintain and improve a Global PV system in accordance with international regulations.
Provide expert advice on GVP compliance and regulatory matters, acting as quality partner to PV Operations (US/DK) and the EU QPPV. Author and maintain GVP Quality procedures and support implementation of new or updated GVP requirements.
In this role, you’ll provide global scientific and technical leadership, contribute to innovation strategies, and act as a thought leader - both within Lonza and the wider biopharmaceutical industry. Guide development of mammalian USP/DSP processes for