Technical Steward (m/f) Production Support, Biopharmaceuticals, Sandoz GmbH Schaftenau
Area of Responsibility
- Provides to the Site the specialist knowledge, as Subject Matter Expert, of specific biopharmaceutical drug substance processes or process technologies (upstream/downstream process, cell culture fermentation, chromatographic separation etc.)
- Oversees processes and standards from the technology perspective to maintain and improve existing and to implement new innovative manufacturing technologies.
- Assures that the necessary benchmark is done internally and externally
- Participate in the definition and selection of pharmaceutical equipment, through providing input to User Requirements (URS)
- Provide the necessary training and education on related technologies to process experts, product stewards and operators.
- Supports process experts and product stewards in trouble shooting.
- Acts as Single Point of Contact (SPoC) for the interface with global MS&T network and with the technical development organization.
- Designs and controls optimization projects relevant to his/her specific expertise.
- Education: University degree (MSc. or PhD) in Biology, Biochemistry, Biotechnology, Biochemical Engineering or equivalent degree
- Languages: German and English fluent
- Experience: 5+ years of professional experience in biopharmaceutical manufacturing/ manufacturing science and technology/ technical development. Proven understanding of up- and downstream technologies (fermentation, chromatographic separation, etc.). Knowledge of quality systems and regulatory requirements across multiple health authorities. Thorough experience in computerized systems and fundamental understanding of applied statistics (MS-office, SAP, Minitab, JMP, etc.). Expert in reviewing and writing (technical) programs and reports.