Process Expert Downstream Processing (DSP) | Process Expert Downstream Processing (DSP) Proteinreinigung & GMP (m/w/d)
expertum GmbH
Job Summary
As a Process Expert in Downstream Processing (DSP), you will play a pivotal role in the development and production of innovative pharmaceuticals at a leading international company in Ulm. Your day-to-day responsibilities involve planning and executing validation studies (RV, PV), identifying and implementing process optimizations for protein purification, and managing Change Controls. You will serve as a Subject Matter Expert (SME), representing the department during audits and ensuring strict adherence to GMP standards. Additionally, you will draft and revise SOPs, conduct batch record reviews, and provide operational support in areas like chromatography and TFF. This role is ideal for a professional with a strong background in biotechnology who thrives in a dynamic, quality-driven environment. You will be instrumental in maintaining data integrity and driving continuous improvement, making this a high-impact position for those passionate about pharmaceutical innovation and regulatory excellence.
Required Skills
Education
Master's or Bachelor's degree in Biotechnology or a related field; alternatively, a scientific vocational qualification (Technician/Master Craftsman) with relevant professional experience.
Experience
- Professional experience in Downstream Processing, specifically protein purification
- Demonstrated experience in GMP environments and process validation
- Experience in managing quality systems and change control processes
- Experience representing technical departments in regulatory audits
Languages
Additional
- Must be eligible to work in Germany. Ability to act as a Subject Matter Expert (SME) in high-pressure situations such as regulatory audits.
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