J-STAR Research, Inc. operates as a contract research organization for pharmaceutical and biotechnology companies worldwide. It offers services in the areas of custom synthesis/contract research, process and analytical research, cGMP synthesis, crystallization process development, solid form screening and selection, pre/early formulation, and drug substance-drug product coprocessing.
- Lead development activities in phase-appropriate solid form selection and physicochemical characterization, such as powder X-ray diffraction, DSC, TGA, SEM, particle size, polarized light microscopy, moisture sorption analysis, solubility, dissolution and stability assessments.
- Map polymorph, salt and cocrystal spaces of drug substances for selection of final solid form for development.
- Understand solid form phase mapping of drug candidates to assist in crystallization process development.
- Develop formulations to support preclinical and Phase I studies including PK, PD, efficacy, tox studies as well as first-in-human.
- Designs experiments, strategies and workflows to improve bioavailability of poorly soluble drug molecules through enabling technologies.
- Interact with clients closely to make sure expectations are met in target timelines.
- MS or PhD in Chemistry, Pharmaceutical Science or related field.
- 0-5 years of experience in solid form selection and preformulation development (solution, suspension, tablet, capsule, etc).
- Good understanding of solid-state chemistry of small molecule drug substances.
- Working knowledge of analytical techniques such as PXRD, TGA, DSC, PLM, DVS, HPLC, NMR and PSD.
- Strong communication, organization, and planning skills.