Senior Analytical Scientist II/III

2 weeks ago

Cranbury, New Jersey, United States J-STAR Research Full time

Company Overview: J-Star Research, Inc. is a leading Contract Development and Manufacturing Organization (CDMO) specializing in the development and optimization of drug substances and drug products. Our comprehensive solutions provide a distinct array of services for new drug candidates, spanning from drug discovery to drug product development for both preclinical and clinical studies.

Position Summary: The primary role of the Analytical Research Scientist II/III is to conduct analytical evaluations of drug substances, intermediates, and drug products to support J-Star's drug product development initiatives. The successful candidate will possess expertise in the characterization of drug product formulations utilizing techniques such as HPLC, GC, DSC, TGA, XRPD, dissolution apparatus, particle size analysis, and Karl Fischer titration.

Key Responsibilities:

  • Conduct analytical evaluations of drug substances, intermediates, and drug products using HPLC, GC, and other methodologies to facilitate pharmaceutical drug product development.
  • Develop and prepare Standard Operating Procedures (SOPs), analytical test methods, and comprehensive reports.
  • Manage the planning and procurement of chemical reagents, excipients, equipment components, and other laboratory supplies.
  • Maintain accurate laboratory notebooks, provide weekly status updates, and compile final project reports.
  • Oversee the calibration, validation, and preventive maintenance of analytical testing instruments.
  • Execute analytical method transfers, validations, and troubleshooting tasks.
  • Ensure the maintenance of a high-quality laboratory environment and adherence to Health, Safety, and Environmental responsibilities.
  • Experience with solid-state characterization techniques such as powder X-ray diffraction, DSC, TGA, SEM, PSD, and polarized light microscopy is advantageous.
  • Possess knowledge of cGMP and ICH regulatory requirements.
  • Perform additional assignments as necessary to achieve company objectives.

Qualifications:

  • Bachelor's degree in a scientific discipline with a minimum of 3 years of relevant experience, or a Master's degree in Chemistry, Pharmaceutical Science, or a related field with 1-3 years of experience.
  • Prior experience in analytical testing of oral and injectable dosage forms supporting various phases of drug product development.
  • Demonstrated proactive problem-solving abilities.
  • Ability to work independently and efficiently, prioritize tasks, and manage multiple projects simultaneously.
  • Exceptional interpersonal, written, and verbal communication skills.

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