ESO MS&T Senior Technical Manager (m/f/d) - Drug Substance

325308BR
Aug 23, 2021
Austria

Job Description

ESO MS&T Senior Technical Manager (m/f/d) - Drug Substance, ESO Large Molecules, Schaftenau, Austria

30+ external active accounts are managed by ESO LM for key Biologic- and Aseptic products incl. launch pipeline for Biosimilars & NBEs with global footprint. The ESO MS&T Senior Technical Manager (m/f/d) acts as key interface between Novartis and the external suppliers to resolve technical challenges, oversee validation activities and evaluate technical changes. The position holder is the major contributor to all manufacturing related questions and topics.

Your Responsibilities:

Your responsibilities include, but are not limited to:
• Represent the technical Interface to external supplier to ensure robust product process capability
• Responsible for process validation oversight & execution at the external supplier
• Ensure successful and well-documented transfers and launches of products with external manufacturing involvement
• Assess impact of technical changes, technical feasibility and scope / design of technical batches
• Lead or support root cause investigation of product and process failures
• Contribute to the registration strategy and ensure alignment of (regulatory) timelines
• MS&T support for technical development of biopharmaceuticals
• Responsible for the technical lifecycle management (e.g.: CPV, process improvements, etc.) together with the CMO

Minimum Requirements

Novartis Technical Operations
NTO LARGE MOLECULES
Austria
Schaftenau
Technical Operations
Full Time
Regular
No
325308BR

ESO MS&T Senior Technical Manager (m/f/d) - Drug Substance

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