Head MS&T - Small Molecules

Job Summary

• Stewardship : ensure robust product stewardship for all products manufactured at the platform / cluster, and end-to-end technical oversight of product manufacturing processes, at all stages of their commercial lifecycle; provide strong technical leadership to ensure product and related packaging operations are maintained in compliance with current GMP and regulatory requirements; ensure that all manufacturing processes are robust respectively process improvement projects acc.
• to project plan are implemented; provide governance of platform Manufacturing Robustness Review Board (MRRB).
• Oversee and ensure the robustness and capability of manufacturing and packaging processes by monitoring of each product s Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs) thru a continued process verification program and review of Annual Product Reviews (APRs) / Product.
• Ensure the robustness of manufacturing and packaging processes, so that all site products are validated and remain in constant state of validation throughout the product lifecycle.
• Ensure single point of contact for products within the site and across sites for multi-site products, as far as process technical issues are concerned.
• Safeguard, maintain and develop the scientific information of product processes.
• Support and, were appropriate, lead optimization of pharmaceutical processes by applying sound scientific reasoning (first principles) and following integrated process and technology strategies, triggering post launch development, when needed.

What you ll bring to the role :  Essential Requirements :

Skills :

Skills Required

r&d, Project Management, Change Management, Process Simulation