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Senior Analytical Scientist

2 months ago

Charles City, Iowa, United States Cambrex Full time
Job Summary

We are seeking a highly skilled Principal Scientist I to join our Analytical Development team at Cambrex. This individual will provide technical support for multiple project teams, evaluating and interpreting analytical results, developing, validating, and transferring analytical methods for APIs, API intermediates, and raw materials.

Key Responsibilities
  • Develop, establish, and validate analytical testing methodologies for raw materials, production intermediates, and final products.
  • Participate in teams to investigate and solve analytical technical issues within Analytical Development, Chemical Development, Process Support Group, and Quality Control.
  • Perform analytical chemistry assays based on new and existing methodologies.
  • Operate analytical instrumentation such as HPLC, GC, GC/MS, FTIR, Titrator, Particle Size Analyzer.
  • Write technical reports to document analytical methods.
  • Maintain laboratory notebooks documenting work.
  • Maintain compliance with GMP SOPs and DEA regulations.
  • Transfer documented analytical methods to the QC and Process Support Group departments.
  • Set up new or existing analytical methods for compound identification, purity, and potency testing.
  • Coordinate off-site testing as necessary.
  • Conduct testing of analytical samples for the Chemical Development Department as needed.
  • Qualify reference materials.
Requirements

We are looking for a candidate with a Ph.D. in Chemistry or a related field with a minimum of 6 years of experience, or an M.S. in Chemistry or a related field with a minimum of 10 years of experience, or a B.S. degree in Chemistry or a related field with 14 years of experience in a lab environment, preferably in the pharmaceutical industry.

The ideal candidate will have demonstrated ability to transfer processes to commercial scale manufacturing, excellent verbal and written communication skills, organizational skills, and the ability to work in a diverse team environment.