Remote Senior Stability-Indicating Method Specialist
TEAM - Total Engine Asset Management
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Job summary
TEAM - Total Engine Asset Management is seeking a Senior Drug Stability-Indicating Method Specialist in a fully remote capacity. You will lead method development, validation, and lifecycle management for stability-indicating analytics, including forced degradation studies and impurity profiling, while coordinating with global labs and QA teams.
The ideal candidate has deep chromatographic expertise (HPLC/UPLC/GC), strong regulatory knowledge (ICH/Q1/Q2), and a track record in pharmaceutical
Qualifications
- Bachelor's degree in Pharmaceutical Chemistry or related field.
- Master's or PhD in Analytical Chemistry or Pharmaceutical Analysis is advantageous.
- Strong experience in pharmaceutical analytical development and stability testing.
Responsibilities
- Lead strategy for developing stability-indicating methods for drug substances and products.
- Review method development plans and ensure suitability for degradation products.
- Provide guidance on forced degradation studies under stress conditions.
- Assess method performance, including accuracy, precision, and robustness.
- Review validation, transfer, and chromatographic data for stability investigations.
- Coordinate remotely with labs and CRO/CMO partners.
Skills
Education
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Job description
TEAM - Total Engine Asset Management is seeking a Senior Drug Stability-Indicating Method Specialist in a fully remote capacity. You will lead method development, validation, and lifecycle management for stability-indicating analytics, including forced degradation studies and impurity profiling, while coordinating with global labs and QA teams.
The ideal candidate has deep chromatographic expertise (HPLC/UPLC/GC), strong regulatory knowledge (ICH/Q1/Q2), and a track record in pharmaceutical
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