Research Associate - Biology
Requirements:
• Established cell culture lab techniques and aseptic processing in an ISO 5 environment such as cell passaging, sampling, fluid handling, media formulation, managing reagents, and cryopreservation.
• Practical knowledge of cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices.
• Fundamental understanding of cell biology principles, sub-population types, differentiation, phenotype markers and metabolic pathways.
• Knowledge of material science and material compatibility for cell culture applications
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products and process development.
Qualification:
• Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development experience required
• 1 to 3 years of pharmaceutical process development experience.
• GMP manufacturing of pharmaceutical products.
• Cell culture aseptic processing, experience with cell therapy products is a plus.
• Use of principles and concepts of Lean Six Sigma or design of experiments to improve process capability is a plus.
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