We are currently seeking an experienced expert (m/f/d) for product transfers and technical processes in the field of sterile drug manufacturing for an internationally operating pharmaceutical company.

Your tasks

• Management and technical support of transfer projects for sterile pharmaceuticals within international production networks
• Conducting technical risk analyses to assess manufacturability, process requirements and transfer strategies
• Definition and evaluation of critical quality, material and process parameters in accordance with regulatory requirements
• Creation, review and maintenance of transfer-relevant documentation in cooperation with quality management and approval
• Analysis of process, transfer and validation data, and derivation of GMP-compliant measures
• Support in handling deviations, investigations and quality-related issues during transfer projects
• Close coordination with internal interfaces from production, supply chain and commercial areas

Your profile

• Completed studies in natural sciences, pharmacy or engineering, or comparable qualification
• Several years of professional experience in the field of sterile drug manufacturing, validation, qualification or process management
• Sound knowledge of regulatory requirements and GMP guidelines in the pharmaceutical environment
• Experience in product transfer, technology transfer, or technical project management is an advantage.
• Knowledge of CMC documentation and eCTD structures is desirable.
• Fluent German and English skills, both spoken and written.
• Structured, analytical work style as well as strong communication and teamwork skills