J-Star Research, Inc. is a Contract Development and Manufacturing Organization (CDMO) focusing on drug substance and drug product development and optimization. Our integrated solutions offer a unique set of services for new drug candidates from drug discovery to drug product development for preclinical and clinical studies.
The primary responsibility in this role is to perform analytical testing of drug substance, intermediates, drug product in support of J-Star’s drug product development projects. The incumbent should provide the expertise in characterization of drug product formulation using HPLC, GC, DSC, TGA, XRPD, dissolution apparatus, particle size analyzer, Karl Fischer titrator. Specifically, the incumbent will be responsible for analysis of formulations from preclinical through clinical formulation development, of oral solids, liquids, injectables and semi-solid dosage forms for new drug candidates.
- Analytical testing of drug substance, intermediates and drug products using HPLC, GC or other techniques to support pharmaceutical drug product development.
- Prepare SOPs, analytical test methods and reports
- Plan and order chemical reagents, excipients, equipment parts and other laboratory supplies.
- Maintain laboratory notebooks, weekly status updates and final project reports
- Perform calibration, validation, and preventive maintenance of analytical testing equipment.
- Perform analytical method transfer, validation and troubleshooting activities.
- Ensure maintenance of high-quality laboratory environment and compliance with Health, Safety and Environmental responsibilities for the position.
- Experience with solid state characterization such as powder X-ray diffraction, DSC, TGA, SEM, PSD and polarized light microscopy is a plus.
- Knowledge of cGMP and ICH requirements
- Perform other assignments as required to meet company objectives.
- Bachelor’s in science with 3+ years of experience or MS in Chemistry, Pharmaceutical Science or related field with 1 -3 years of experience.
- Previous experience in analytical testing of oral, injectable dosage forms supporting various phases of drug product development.
- Proactive in problem-solving. Ability to work independently and effectively, prioritize and manage multiple projects and activities, commit to the assignments in a timely manner.
- Excellent interpersonal, written, and verbal communication skills.