Technical Expert MS&T (Large Molecules)

Your Key Responsibilities :

Your responsibilities include, but not limited to :

Technical Support to internal Manufacturing Sites and CMO s :

• As a Technical Expert to the assigned manufacturing site internally or CMO, ensure and improve product process capability, to keep the knowledge of process up to date and to maintain the product in constant state of validation.
• Implement Science- and Risk-based approaches to ensure that product quality can be sustainably reproduced.
• Ensure the availability of all relevant Technical Documentation such as protocols, reports, Risk Assessments, Concept papers, Scientific Justifications based on significant body of information generated regarding the product & the process ahead of the planned activities at the respective sites

Product / Technical Stewardship for assigned sites :

Validation Support - for product(s) / Sites assigned :

Launch & Transfer Support - for product(s) / Sites assigned :

Interface to Development for the product(s) / Sites assigned :

Manufacturing & Operational Excellence - for defined product(s) / Sites assigned :

Training :

What you ll bring to the role :

Minimum Requirements :

Education (minimum / desirable) :

Languages :

Fluent in English & Local Language of the respective Country.

Relevant Experiences :

Skills Required

Project Management, drug development, Data Handling, Technical Support