Senior Analytical Scientist

2 weeks ago


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

J-Star Research, Inc. operates as a Contract Development and Manufacturing Organization (CDMO) specializing in the development and optimization of drug substances and drug products.

Our comprehensive solutions provide a distinctive array of services for emerging drug candidates, guiding them from initial discovery through to product development for both preclinical and clinical studies.


Position Summary:

The primary focus of this role is to conduct analytical evaluations of drug substances, intermediates, and final 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, and particle size analysis.

Key responsibilities include:

  • Conducting analytical evaluations of drug substances, intermediates, and final products using HPLC, GC, and other methodologies to facilitate pharmaceutical product development.
  • Drafting Standard Operating Procedures (SOPs), analytical testing methods, and comprehensive reports.
  • Coordinating the procurement of chemical reagents, excipients, equipment components, and laboratory supplies.
  • Maintaining accurate laboratory notebooks, providing weekly status updates, and compiling final project reports.
  • Executing calibration, validation, and routine maintenance of analytical testing instruments.
  • Overseeing analytical method transfers, validations, and troubleshooting processes.
  • Ensuring adherence to high-quality laboratory standards and compliance with Health, Safety, and Environmental regulations.

Experience with solid-state characterization techniques, including powder X-ray diffraction, DSC, TGA, SEM, PSD, and polarized light microscopy, is advantageous.

Familiarity with cGMP and ICH guidelines is essential.

Qualifications:

A 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 across various stages of drug product development is required.

The ideal candidate will demonstrate proactive problem-solving abilities, possess the capacity to work independently and efficiently, and manage multiple projects and responsibilities effectively.

Exceptional interpersonal, written, and verbal communication skills are essential for success in this role.



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