We are looking for an experienced and motivated Production Manager Pharma (m/f/d) who combines strong technical expertise with a pragmatic, solution-oriented approach to join our team in Aachen.
In this role, you will be the Subject Matter Expert (SME) for drug product manufacturing and ensure that our commercial manufacturing activities are performed reliably, on time and in compliance with applicable GMP requirements.
You will work closely with or Contract Manufacturing Organizations (CMOs) as well as Quality Assurance, Regulatory Affairs and other internal and external partners.
Your Responsibilities
- Act as the Subject Matter Expert (SME) for all aspects of PAION’s drug product manufacturing activities
- Manage and coordinate the interaction with Contract Manufacturing Organizations (CMOs) involved in the manufacture of PAION’s drug products
- Review manufacturing documentation, including Master Batch Records, and ensure compliance with current GMP requirements, relevant ICH guidelines, PAION specifications and internal procedures
- Manage production-related deviations, change controls, risk assessments and validation activities
- Support process validation, lifecycle management and continuous improvement of manufacturing processes
- Review, maintain and continuously improve manufacturing processes, including implementation of changes resulting from updates to EU GMP and other applicable international GMP requirements
- Provide production-related SME support to licensees, including the organization and execution of manufacturing process transfer programs.
- Work in close cooperation with the Regulatory Affairs team and provide technical input for the preparation, review and maintenance of regulatory documentation and submissions
- Support GMP audits and inspections as the manufacturing SME expertise