Associate Scientist

2 weeks ago

Northampton, United States Medix Full time
Job Description
  • Adhere to all relevant current Good Manufacturing Practices (cGMP) regulations and laboratory safety protocols.
  • Conduct extractable and leachable testing for various pharmaceutical products, manufacturing components, and medical devices, ensuring compliance with cGMP guidelines.
  • Develop, validate, and enhance innovative analytical methods for extractable and leachable testing utilizing HPLC/MS and/or GC/MS.
  • Produce technical documents such as test methods, protocols, reports, and procedures.
  • Perform technical reviews of data and reports generated by fellow scientists to verify accuracy, completeness, and adherence to relevant specifications and procedures.
  • Address issues, perform maintenance, and facilitate the integration of new analytical instruments, including LC/MS and GC/MS.
  • Collaborate with interdisciplinary teams to guarantee compliance with Good Manufacturing Practices (GMP) standards.

Qualifications
  • Bachelor's degree in chemistry, analytical chemistry, or a related field. A Master's degree is acceptable; however, a PHD is not preferred.
  • Proficiency in Microscopy (experience with microscopes) OR Chromatography, depending on team requirements.
  • Robust understanding of chromatography techniques, encompassing method development, troubleshooting, and data interpretation.

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