Bioprocess Specialist DSP

Responsibilities

• Establish selected DSP process steps using single-use materials, including equipment commissioning and qualification (DQ/IQ/OQ)
• Plan and implement performance qualification activities (PQ, PPQ)
• Create and review risk analyses, qualification documents, and other GMP documentation
• Establish GMP-compliant manufacturing instructions (Master Batch Records) and review recipes/methods
• Manage operational readiness tasks including material management, sample handling, and EHS topics
• Execute and supervise GMP-compliant production of monoclonal antibodies in cleanroom conditions (500 L – 2000 L scale)
• Train new employees on production processes and manage deviations and change controls in collaboration with Quality Management
• Optimize process workflows and oversee maintenance activities

Requirements

• University degree in Biotechnology or a comparable qualification (or technical training with extensive professional experience)
• In-depth knowledge and several years of experience in the manufacturing of biological substances within the DSP area
• Proven experience working in a GMP-regulated environment
• Proficiency in Microsoft Office applications
• Fluency in both German and English (excellent oral and written skills)
• Willingness to work in a two-shift operation

Preferred Qualifications

• Experience in a biopharmaceutical company
• Specific experience in monoclonal antibody manufacturing

About the Company

Daiichi Sankyo is a global healthcare company dedicated to improving lives through innovative medicines. With a legacy dating back to 1899 and a presence in over 30 countries, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.