You main responsibility will be the development and management of the downstream processes for API.
Role and responsibility:
In collaboration with customer project team, develop the downstream processes:
- At the level of the laboratory, define and organize all experimental work needed to design/qualify processes in terms of quality,robustness, productivity and safety, fitting with requirements and timelines of the customers.
- Manage the process scale up and manufacturing batches (cGMP) including development, qualification and validation batches (in collaboration with manufacturing department). Manage all the associated documentation (MBrs, DMR, protocols, development reports, change over, …) and logistics with the supply chain department (Raw materials, planning,...).
- Maintain operation in compliance with the cGMP PPG quality system (preparation and review of batch records, preparation for audits, audit follow-up, assist RA for CMC, NDA, DMF filing.
- Ensure successful transfer of the process as process giver to the manufacturing or as process receiver for Technology transfers from others PPG sites.
- Work as part of the project team to meet the project timelines and the budget. Regularly keep the customers (both internal and external) informed all over the different phases of the project program, through projects team meetings, regular conference calls and weekly written updates (Plan-do-check-adjust).
- Support manufacturing for troubleshooting activities and process optimization.
- Contribute to the maintenance of the scientific excellence of the department in the field of downstream process and evaluate the possibility to implement innovative ideas and new technologies allowing to improve quality and productivity.
- Contribute to the enforcement of a quality environment and system specifically designed for development activities.
- Contribute to the laboratory organization, equipment management. Sustain 5S, lean management and SHE rules.
- Ensure the people management of the technical staff devoted to the corresponding project programs (direct and dotted reports).
- Contribute to the harmonisation of technical practises and documentation following the global Development guidances.