Pharmaceutical Analytical Specialist

3 weeks ago


Sacramento, California, United States Nivagen Pharmaceuticals Full time
Job Summary

We are seeking an experienced Research Chemist (Analytical) with a minimum of 2-5 years of pharmaceutical industry experience.

The successful candidate will play a critical role in analytical development for complex parenteral/injectable drug products including peptides, suspensions, solutions, and lyophilized products.

Key Responsibilities:

  • Maintain, Operate and troubleshoot LC-MS Systems.
  • Perform extraction, analysis, and characterization of Extractables and leachable from polymeric materials associated with container closure systems of pharmaceutical drug products as per PQRI, ICH, and other regulatory guidelines.
  • Develop and validate LC-MS methods for finished product and raw material characterization and extractable/leachable testing.
  • Unknown impurity identifications using LC-MS and LC-MS/MS or other suitable techniques.
  • Interpret complex spectral data and fragmentation patterns.
  • Routine stability testing of API, finished product samples for assay and impurities using LC-MS systems.
  • Generate study designs, write protocols, methods, datasheets, and reports.
  • Provide support in critical review of analytical data, reports, and protocols.
  • Attend SOP, Safety, and scientific trainings to remain current with cGMP regulations, safety standards, and development technologies.
  • Preparation and review of analytical methods, method validation, and related study reports for ANDA/NDA submissions and support, document preparations for ANDA/NDA submissions.
  • Any other activities as directed by the supervisor.

Requirements:

  • Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field.
  • Analytical Chemistry or a related field with 1-2 years of hands-on experience in handling LC-MS systems (Qtof, Tandem Quad).

Estimated Salary: $75,000-$85,000 per Year



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