Senior Drug Stability Indicating Method Specialist

Location: United Arab Emirates (Remote)

Employment Type: Full-Time

Work Arrangement: 100% Remote — Work From Home

Level: Senior

The Senior Drug Stability-Indicating Method Specialist is responsible for reviewing, evaluating, and supporting the development and validation of analytical methods used to assess pharmaceutical product stability, degradation profiles, and impurity levels. The role focuses on analytical method performance, forced degradation study review, stability-indicating capability assessment, chromatographic data interpretation, validation documentation, and regulatory readiness. Working fully remotely, the specialist collaborates with analytical development, quality control, quality assurance, formulation, manufacturing, and regulatory affairs teams to ensure that stability-indicating methods are scientifically sound, appropriately documented, and aligned with applicable pharmaceutical quality standards.

• Review and evaluate analytical methods designed to distinguish active pharmaceutical ingredients from degradation products, impurities, and excipients.
• Assess stability-indicating method suitability for pharmaceutical substances, finished products, and relevant formulation types.
• Review forced degradation study protocols, results, and supporting scientific justifications.
• Evaluate analytical data generated under stress conditions, including acid, base, oxidation, heat, humidity, and photolytic exposure.
• Review chromatographic methods, including HPLC, UHPLC, and related analytical techniques used in stability testing.
• Assess method specificity, accuracy, precision, linearity, range, robustness, and other relevant validation characteristics.
• Examine impurity profiles, degradation pathways, peak purity results, mass balance assessments, and analytical trends.
• Review analytical method validation and verification reports for scientific completeness and consistency.
• Evaluate the suitability of reference standards, system suitability criteria, sample preparation procedures, and analytical acceptance limits.
• Review stability study protocols, analytical results, trend reports, and supporting documentation in accordance with approved procedures.
• Identify analytical discrepancies, unexplained degradation patterns, atypical results, and potential out-of-specification or out-of-trend findings for appropriate escalation.
• Assess method transfer and method verification documentation between development, quality control, and external testing laboratories.
• Coordinate with laboratory scientists and analytical development specialists to resolve technical questions and documentation gaps.
• Review analytical procedures, specifications, validation protocols, and controlled method documentation.
• Support investigations into analytical method failures, chromatographic interference, inconsistent impurity results, and stability-related deviations.
• Evaluate the impact of formulation changes, manufacturing process modifications, packaging systems, and storage conditions on analytical method suitability.
• Support the preparation and review of pharmaceutical regulatory documentation relating to analytical methods and stability studies.
• Monitor relevant developments in ICH guidance, pharmacopoeial standards, and pharmaceutical analytical quality requirements.
• Prepare technical summaries, analytical review reports, method performance assessments, and management updates.
• Recommend improvements to analytical method lifecycle management, data integrity controls, and stability documentation practices.

• Bachelor's degree in Pharmaceutical Sciences, Analytical Chemistry, Chemistry, Pharmaceutical Analysis, or…