Senior Drug Stability Indicating Method Specialist

Job Title:

Senior Drug Stability-Indicating Method Specialist

Location: United Arab Emirates (Remote)

Employment Type: Full-Time

Work Arrangement: 100% Remote — Work From Home

Level: Senior

We are seeking an experienced Senior Drug Stability-Indicating Method Specialist to provide technical expertise in the development, evaluation, validation, and lifecycle management of analytical methods used to assess pharmaceutical product stability. The role focuses on reviewing analytical method performance, evaluating degradation profiles, interpreting chromatographic data, assessing method specificity, and supporting pharmaceutical quality and stability documentation.

This is a fully remote technical specialist position focused on analytical data review, method documentation, scientific evaluation, and virtual coordination with pharmaceutical development, quality control, quality assurance, and regulatory teams. Physical sample handling, chemical preparation, laboratory experiments, instrument operation, and analytical testing must be performed by qualified local laboratory personnel. Formal method validation approvals, product release decisions, regulatory submissions, and statutory quality sign-offs must be completed by appropriately authorized professionals.

• Review stability-indicating analytical methods used to evaluate pharmaceutical drug substances and finished products.
• Assess analytical method suitability for detecting and quantifying active pharmaceutical ingredients and relevant degradation products.
• Evaluate chromatographic data, including HPLC, UPLC, GC, and other applicable analytical techniques.
• Review forced degradation study results and assess evidence supporting method specificity and stability-indicating capability.
• Analyze degradation pathways, impurity profiles, peak purity results, and potential interference from excipients or formulation components.
• Review analytical method development reports, validation protocols, validation reports, and transfer documentation.
• Assess method performance characteristics, including accuracy, precision, specificity, linearity, range, robustness, and sensitivity.
• Review system suitability results, chromatograms, integration parameters, and analytical sequence records.
• Identify analytical discrepancies, unexpected degradation trends, method limitations, and potential data integrity concerns.
• Support the technical evaluation of stability studies under applicable storage conditions and testing intervals.
• Review stability data for consistency, completeness, trend patterns, and potential out-of-specification or out-of-trend results.
• Coordinate remotely with analytical development scientists, laboratory analysts, quality control teams, and pharmaceutical formulation specialists.
• Support investigations into analytical deviations, atypical results, method failures, and stability-related discrepancies.
• Review analytical method transfer packages and assess consistency between originating and receiving laboratory documentation.
• Prepare technical assessments, analytical review summaries, investigation reports, and method lifecycle documentation.
• Support the development and maintenance of analytical method procedures, technical standards, and controlled documentation.
• Monitor relevant scientific publications, pharmacopeial standards, and regulatory guidance concerning pharmaceutical stability and analytical validation.
• Recommend improvements to analytical review practices, method robustness, documentation quality, and stability data management.

• Bachelor's degree in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, Pharmacy, or a related scientific discipline.
• Significant experience in pharmaceutical analytical development, stability testing, analytical method validation, or quality control.
• Strong understanding of stability-indicating analytical methods and pharmaceutical degradation studies.
• Practical knowledge of HPLC, UPLC, GC, UV spectroscopy, and other relevant analytical techniques.
• Experience reviewing forced degradation studies, impurity profiling, chromatographic data, and analytical validation reports.
• Understanding of analytical validation principles, including specificity, accuracy, precision, linearity, range, robustness, and detection limits.
• Familiarity with ICH stability and analytical validation guidelines, relevant pharmacopeial requirements, and pharmaceutical GMP principles.
• Knowledge of pharmaceutical stability protocols,…