Scientist III, Analytical R/D - Durham, NC

Only for registered members Durham, NC , United States

1 month ago

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Job summary

The Scientist III/ Sr. Scientist is responsible for developing and validating analytical methods to support drug formulation development in a GMP-compliant laboratory.
This role involves performing validations, stability testing, and forced degradation studies while ensuring data integrity and regulatory compliance.
The scientist will independently manage projects, including literature reviews, experimental design, execution, and reporting.,
Responsibilities also include authoring technical documents such as method validation protocols,
development reports,
and SOPs,
as well as troubleshooting analytical instrumentation like HPLC and GC.
Additionally,
the role requires mentoring junior scientists,
collaborating with cross-functional teams such as Formulation R&D,,
Quality Control,,
& Quality Assurance,,

Skills

  • Knowledge of cGMP regulations & ICH,, USP,, & FDA guidelines
  • ,
  • Techincal report writing proficiency preferred
  • ,

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