Website J-Star Research, Inc.
Research Chemist with MS degree in Chemistry, Chemical Engineering or related field with 6 months of research experience wanted for J-Star Research, Inc. in Cranbury, NJ to:
- perform API crystallization process in compliance with cGMP and FDA regulations, utilizing analytical tools including chromatography, separation, and solvent selection;
- support crystallization process development by conducting studies involving compound properties and experimental conditions;
- participate in the scale-up development of enabling technology and experiments to facilitate the co-processing and development of API;
- conduct routine stability, performance, and evaluation studies for solid state characterization and pre-formulation support;
- support early drug crystallization process development for high potency compounds and controlled substance;
- purify pharmaceutical compounds using column chromatography, crystallization, trituration, extraction, and distillation;
- utilize experimental and simulation/modeling approaches to perform solvent selection and solve process challenges arisen from scale-up crystallization process;
- collect, analyze and maintain data integrity under Good Documentation Practice;
- write/review developmental chemistry, process optimization and process scale-up reports to support FDA requirements for CMC (Chemistry, Manufacturing and Control) sections of INDs/NDAs.
Must have knowledge of API processing, Crystallization, Chromatography, Distillation.
Submit resume to Human Resources, J-Star Research, Inc., 6 Cedarbrook Drive, Cranbury, NJ 08512