Your tasks
We are looking for a Production Manager Drug Product (m/f/d) to join our team in Aachen to ensure that the manufacturing of our drug products meets our commercial requirements from the manufacturing / production perspective.
Responsibilities / Main Tasks
- Become the Subject Matter Expert (SME) for all aspects of PAIONs Drug Product manufacturing activities.
- Manage the interaction with PAIONs drug product CMOs as the SME
- Review manufacturing documentation (Master Batch Records) and ensure manufacturing activities are conducted in-time and in accordance with current GMP guidelines, relevant ICH requirements, PAION specifications and procedures.
- Perform and support Life Cycle Management and Continuous Improvement of manufacturing processes including process validation activities
- Review and update / improve manufacturing processes as appropriate, including changes / updates of EU GMP guidelines and GMP guidelines of other territories in the interest of PAION.
- Manage production related change controls and deviations as well as validation reports and risk assessments
- Provide support to licensees as SME in production related topics where applicable, including the organization and support of manufacturing process transfer programs
- Provide technical support with the writing and maintenance of registration documentation
- Provision of subject matter expertise to support audit of manufacturing / testing facilities in accordance with GMP, current guidelines and internal procedures.