Sr. Scientist - Pharmacopoeia Job at Thermo Fisher Scientific, Boston, MA

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  • Thermo Fisher Scientific
  • Boston, MA

Job Description

Senior Scientist position supporting pharmacopeial analytical methods and compendial testing strategies at a contract research organization. The role involves evaluating global pharmacopeial standards, developing method verification approaches, and managing analytical change controls in a quality management system.

Responsibilities

  • Serve as subject matter expert for compendial analytical methods across global pharmacopeial standards
  • Evaluate impact of pharmacopeial revisions and updated monographs on analytical methods and product specifications
  • Develop method verification, transfer strategies, and acceptance criteria with supporting technical documentation
  • Initiate and implement analytical change controls including risk assessments and impact analyses
  • Support investigations of atypical results, out-of-specification findings, and laboratory deviations

Requirements

  • Bachelor's degree in Chemistry, Biochemistry, Material Science, Biology, or related laboratory science
  • 4+ years relevant experience, or Master's degree with 2+ years experience, or PhD
  • Deep knowledge of USP, EP, JP, ChP and other global pharmacopeial standards
  • Experience interpreting pharmacopeial monographs and compendial requirements
  • Experience verifying and transferring compendial methods to quality and manufacturing laboratories
  • Proficiency authoring analytical change controls and technical documentation in QMS systems
  • Strong technical writing and communication skills

Compensation: $90,000–$100,000

Job Tags

Contract work

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