Biotech Upstream Process Development Analyst

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DEMO Pharmaceuticals

Responsible for technical support for bioreactor operations lab scale as well as pilot scale.
Responsible for daily monitoring of the bioreactors and keeping thorough record of cell culture parameters and results into lab data sheets and/or electronic note books.
Perform upstream processing development activities and optimization of manufacturing processes.
Participate in the technology transfer from contract manufacturing organization, may perform duties in the plant.
Participate in the technology scale-up from laboratory to pilot and commercial scale.
Provide technical support during process development and manufacturing activities.
Assist in the 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).
Set up and execute process development experiments as required.
Perform process characterizations studies.
Prepare investigation reports on deviations from the GMP manufacturing process.
Responsible for experimental data analysis and documentation.

BSc/B.Tech in biology, biotechnology, or related field.
MSc/M.Tech degree in a field related to biotechnology, bioengineering, biochemistry, or molecular biology will be highly appreciated.
Familiar with basic laboratory techniques, including but not limited to: aseptic expansion of mammalian cell culture and routine analytical procedures on cell culture samples.
Have a good understanding of cell culture parameters in general (cell growth rate, cell density, viability, metabolites consumption, etc).
Experience in upstream processing of biotherapeutics (biosimilars and monoclonal antibodies preferred) will be considered an asset.
Knowledge of small-scale bioreactors as well as pilot scale bioreactors will be considered an asset.
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
Excellent communication skills both verbal and written.
Strong organization skills. Attention to detail.
Strong problem-solving attitude, critical thinking.
Resilience and ability to work under pressure.