Upstream Process Development Scientist
Experience in development of mammalian cell culture processes for the production of recombinant proteins is a plus. • Knowledge of protein chemistry and purification techniques and purification process development experience is preferred. • Basic knowledge of cGMP policies and procedures. Basic knowledge of regulatory requirements of the pharmaceutical / biotechnology industry.
Key Responsibilities:
• Design and execute experiments for production of proteins using microbial fermentation processes. Design, analyze and interpret lab experiments, purification data, in-process trends, productivity and quality attributes to support upstream process development.
• Lead efforts to evaluate different fermentation media, feeds, and feeding strategies to improve product yield and quality including proper folding of protein
• Scale up process developed at research stage to manufacture adequate amounts of protein to support clinical trials
• Author technical documentation including process validation protocols and reports.
Evaluate process robustness, investigate causes of process variances, and take steps to maximize process reproducibility.
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