Your tasks

• They are responsible for the professional and disciplinary management of the Clinical Manufacturing Plant (CMP) and for the strategic development of the department and its employees.
• They plan, control and are responsible for the production of preclinical and clinical investigational medicinal products according to cGMP/GCP and ensure a cGMP-compliant manufacturing operation.
• They assume the function of managing the production of clinical trial materials in accordance with Sections 12 and 13 of the AMWHV (German Medicines and Active Pharmaceutical Ingredients Ordinance).
• They develop and optimize safe and efficient manufacturing processes for biopharmaceutical agents on a pilot scale and plan the necessary workflows and resources.
• They obtain the qualified condition and cGMP status of the CMP, implement regulatory requirements and ensure continuous inspection readiness.
• They approve relevant manufacturing, validation and qualification documents, specifications, deviations, risk analyses and other cGMP-relevant documentation.
• They plan staffing needs and cost centers, promote the professional development of employees, and participate in project groups and, if necessary, in the management of sub-projects.
• They represent the CMP in projects and audits/inspections.

Your profile

• Completed studies in natural sciences or engineering, ideally with a doctorate
• Several years of experience in cGMP-compliant production, ideally in the manufacture of clinical trial materials, as well as sound knowledge in protein purification and scale-up.
• Sound knowledge of cGMP requirements as well as experience with qualification and validation.
• Experience in GMP documentation, deviation management and risk analysis
• Several years of experience in disciplinary management as well as strong planning and control skills.
• Excellent German and English skills, both spoken and written.
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