Upstream Process Development Scientist

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. 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.