Biotech Upstream Process Development Scientist
Biotech Upstream Process Development Scientist
DEMO Pharmaceuticals
Athens, Greece
Main duties and responsibilities
- Perform upstream processing development and process optimization activities;
- Participate in the technology transfer from contract manufacturing organization and may perform duties in the plant;
- Participate in the process scale-up from laboratory to pilot and commercial scale;
- Participate and perform process scale down model development and process characterization studies;
- Assist in risk management strategies, adoption of newer technologies for upstream functional activities;
- Review all process related documentation at every stage: process development, transfer, scale-up, scale-down, characterization and manufacturing;
- Set up, execute, and provide technical support during process development and manufacturing activities;
- 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);
- Prepare technical documents, updates to senior management and manage the cell culture operations for enabling routine activities;
- Prepare investigation reports on deviations from the GMP manufacturing process;
- Responsible for experimental data analysis using statistical tools and documentation;
- Experienced in the DoE principles and able to apply them in the process development experiments;
- Abilities to seamlessly work with multiple cross functional teams to deliver on program timelines.
Requirements
- MSc in biology, biotechnology, or related field;
- PhD degree in a field related to biotechnology, bioengineering, biochemistry, or cell-culture will be highly appreciated;
- 1-3 years in upstream processing of biotherapeutics (biosimilars and monoclonal antibodies preferred);
- Sound knowledge of regulations required for 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.
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