Role Overview
The role of Manufacturing Process Coordinator is crucial in the execution of our Production Schedule, focusing on delivering outstanding results across safety, quality, supply, and cost fundamentals.
This position takes end-to-end ownership of clinical API manufacturing programs, interfacing with cross-functional teams and overseeing all aspects of technical transfer from early engagement to start-up, manufacturing, and delivery.
Main Responsibilities:
* Technical transfer of processes from R&D laboratories and the Kilo Lab into the manufacturing facility (batch & continuous).
* Determination of optimal process fits/equipment configurations to meet process requirements.
* Understanding and utilization of manufacturing control systems for generating and executing processing steps.
* Troubleshooting plant batch and continuous manufacturing operations.
* Clinical process development.
* Participation in co-development, launch, and technical transfer of processes from the manufacturing site to the commercial organization.
* Collaboration with Quality Operations, Analytical R&D, Logistics, Global Materials Management, Engineering, and other partner functional lines.
* Development of procedures, training, manufacturing, and cleaning records, as well as documentation required for cGMP manufacturing.
* Engagement in Continuous Improvement initiatives to deliver efficiencies and speed to market for new product introductions.
* Accurate manufacturing execution against safety, quality, and customer service metrics for clinical campaigns conducted within the site.
* Monitoring and optimization of the quality and yield of products, including the optimization of the process regarding efficiency, quality, and safety.
* Real-time analysis of data (e.g., Process Analytical Technology data) and real-time decision-making in partnership with Pharm Sci colleagues.
* Data collection, trending, and generation of technical reports.
* Leading post-campaign reviews with Pharm Sci colleagues.
* Participation in cross-functional teams to achieve site goals.
* Collaboration with analytical colleagues to ensure effective integrated process analytics and control.
* Support for digital initiatives and new technologies.
* Leadership and support for investigations and resolution of issues that may occur on the plant.
* Completion of personal training in compliance with procedures as part of a comprehensive learning and development program.
* Training and support to new staff members of the manufacturing team to ensure that learning objectives are met.
* Maintenance of readiness for and participation in routine safety inspections, regulatory inspections, and audits.