Upstream Process Development

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.

Basic qualifications: • Ph.D., MS or BS in Chemical/Biochemical Engineering or related Biological Sciences is required. For a candidate with a Ph.D. >3 yrs. of industrial experience; candidate with an MS >5 yrs. industrial experience and for a candidate with a BS, >7 years of industrial experience in developing upstream microbial fermentation processes for the production of bio-pharmaceuticals is required. Specific experience in development of microbial expression processes for soluble protein production is preferred.