Comprehensive understanding of scale up, technology absorption, Product transfer, process optimization, product robustness and process performance qualification operations.
Ensure scientific assessment into the Manufacturability, robustness, scalability and suitability for the available equipment at facility for the drug products introduced at sites and guide team for robust process development during new product introduction.
Technical coordination with R&D;/PDL/Production team for execution of Development/Exhibit/Process Validation batches/Recent Launches.
Bridge with development and ensure absorption of complete technology of new/transferred products from R&D;/PDL and same to be extended to shop floor for smooth commercialization as well as ahead-of-schedule escalation of challenges with resolution plan.
Ensure monitoring of process performance and competent resolution of technical product issues of all new product introductions/site transfers/ Re PPQ programme at the site to ensure manufacturability of products in the available equipment train in line with equipment occupancy, capability, and qualification ranges.
Oversee all aspects of technical manufacturing processes & manufacturability of products including process capability (Cpk & Ppk) to ensure the robustness of existing products and new/transferred products before commercialization from the site.
Review of critical process parameters, support finalization of BPR parameters, support for assessment & detect the variability, identification & resolution of issues, and timely escalation of challenges of all new products after scale-up/exhibit/validation batches to ensure manufacturability& compliance to limits/specifications during commercial manufacturing.