Senior Stability-Indicating Method Expert (Remote)

Therapy Essence

Abu Dhabi

Remote

AED 800,000 - 1,200,000

Full time

3 days ago
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Benefits offered by this job

Remote work
Competitive compensation
Career progression

Job summary

Therapy Essence is seeking a Senior Drug Stability-Indicating Method Specialist to develop, optimize, and validate stability-indicating analytical methods for drug substances and products. This fully remote role requires expertise in forced degradation, chromatographic techniques, and regulatory documentation, with collaboration across labs and QA teams.

The candidate will review degradation studies, interpret analytical data, and ensure methods meet ICH, GMP, and pharmacopoeial expectations

Qualifications

  • Bachelor's or master's in Pharmaceutical Sciences or related field.
  • Significant experience in analytical method development and stability testing.
  • Strong understanding of forced degradation studies and related impurity assessment.
  • Experience with HPLC/UPLC/GC and spectroscopy.
  • Familiarity with ICH guidelines and GMP/GLP principles.

Responsibilities

  • Develop, review, and optimize stability-indicating methods for APIs and products.
  • Evaluate procedures to distinguish active ingredients from degradants and impurities.
  • Support forced degradation study protocols under stress conditions.
  • Review degradation pathways and impurity formation with analytical data.
  • Oversee method transfer and documentation for regulatory submissions.
  • Maintain data integrity and controlled documentation across projects.
  • Provide remote guidance and training to lab teams.

Skills

Analytical method development
Forced degradation studies
Regulatory documentation
Chromatographic techniques
Data interpretation
Regulatory compliance
Remote collaboration
Technical writing

Education

Bachelor's or Master's in Pharmaceutical Sciences/Analytical Chemistry

Tools

HPLC
UPLC
GC
UV-Visible spectroscopy

Job description

Therapy Essence is seeking a Senior Drug Stability-Indicating Method Specialist to develop, optimize, and validate stability-indicating analytical methods for drug substances and products. This fully remote role requires expertise in forced degradation, chromatographic techniques, and regulatory documentation, with collaboration across labs and QA teams.

The candidate will review degradation studies, interpret analytical data, and ensure methods meet ICH, GMP, and pharmacopoeial expectations

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