Upstream Process Development Scientist
- 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.
- 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.
Merck
latentlabs