Upstream Process Development

Job description

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. A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.