Your tasks
We are looking for a Production Manager Pharma (m/f/d) to join our team in Aachen to ensure that the manufacturing of our APIs and 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 API and Drug Product manufacturing activities.
- As the SME manage the interaction with PAIONs CMOs for the manufacture of our APIs and Drug Products
- 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.
- Manage production related change controls and deviations as well as validation reports and risk assessments
- 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 required due to updates of EU GMP guidelines and GMP guidelines of other territories in the interest of PAION.
- Provide support to licensees as our SME in production related topics where applicable, including the organization and support of manufacturing process transfer programs
- In cooperation with out regulatory team, provide technical support with the writing and maintenance of registration documentation
- Provision of subject matter expertise to support audits of manufacturing facilities in accordance with GMP, current guidelines and internal procedures.