Biotech Upstream Process Development Senior Scientist

Biotech Upstream Process Development Senior Scientist

DEMO Pharmaceuticals

Athens, Greece

Main duties and Responsibilities:

• Design and execute early stage as well as late-stage mammalian cell culture experiments at both lab and pilot scales.
• Hands on experience with High-throughput bioreactor systems like Ambr250.
• Perform process optimization leading to the process lock.
• Assist in the design and execution of experimental plans to understand the process and its robustness (Identification and characterization of Critical Process Parameters and their link with Critical Quality Attributes).
• Provide technical support, develop process scaleup strategies, prepare risk assessments and support technology transfer from laboratory to pilot and to commercial scale.
• Review process development, process transfer, scale-up batches and documentation.
• Perform SDM establishment and qualification & design and perform Process Characterization studies.
• Responsible for experimental data analysis and documentation.
• Experienced in the DoE principles and able to analyze complex datasets using statistical tools (e.g., JMP DoE, MVDA, etc.).
• Document experimental protocols, results, and technical reports in compliance with R&D, QA & regulatory standards.

Requirements:

• MSc in biology, biotechnology or related field.
• PhD degree in a field related to biotechnology, bioengineering or biochemistry will be highly appreciated.
• Strong background and hands-on experience 5-8 years in upstream processing of biotherapeutics (biosimilars and monoclonal antibodies preferred).
• Proficiency in operating and troubleshooting bioreactors (Lab & Pilot scale).
• Sound knowledge of regulations required for analytical development of biotech products, preferably in biosimilars development.
• Excellent communication skills both verbal and written.
• Strong problem-solving attitude, critical thinking.
• Resilience and ability to work under pressure.
• Team player.