Senior Drug Stability Indicating Method Specialist Job UAE/Dubai,Pharmaceutical

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

About the Role

We are seeking an experienced Senior Drug Stability-Indicating Method Specialist to lead the development, validation, assessment, and lifecycle management of analytical methods used to evaluate pharmaceutical drug stability. The successful candidate will provide technical expertise in stability-indicating analytical procedures, forced degradation studies, impurity profiling, method validation, and pharmaceutical quality documentation.

This fully remote role will support pharmaceutical development and quality teams through analytical data review, method development strategy, technical documentation, and virtual coordination with qualified laboratory personnel. The ideal candidate will have strong knowledge of chromatographic techniques, analytical chemistry, pharmaceutical stability testing, and applicable regulatory guidelines.

Key Responsibilities

Lead the scientific strategy for developing and evaluating stability-indicating analytical methods for pharmaceutical drug substances and drug products.
Review analytical method development plans to ensure methods are suitable for identifying and quantifying relevant degradation products.
Provide technical guidance on forced degradation studies under appropriate stress conditions, including hydrolytic, oxidative, thermal, and photolytic conditions.
Assess the specificity, selectivity, sensitivity, accuracy, precision, and robustness of analytical methods.
Review HPLC, UPLC, GC, and other relevant analytical procedures used in pharmaceutical stability investigations.
Evaluate chromatographic separation of active pharmaceutical ingredients, process impurities, and degradation products.
Review method validation and verification protocols, acceptance criteria, and supporting analytical results.
Assess method transfer documentation and comparability results between laboratories and analytical instruments.
Interpret analytical data generated from accelerated, intermediate, and long-term stability studies.
Review impurity profiles and degradation pathways to support pharmaceutical product development and quality assessments.
Evaluate analytical method performance, including system suitability, peak purity, resolution, and reproducibility.
Investigate analytical deviations, atypical results, out-of-specification results, and unexpected degradation trends.
Provide technical recommendations for analytical method optimization and troubleshooting.
Review stability-indicating method protocols, reports, chromatograms, calculations, and raw data summaries.
Support the establishment and justification of shelf-life, retest periods, and stability specifications through appropriate analytical evidence.
Ensure analytical methods are aligned with applicable ICH guidelines, pharmacopoeial requirements, and relevant regulatory expectations.
Coordinate remotely with analytical development laboratories, quality control teams, contract research organizations, and contract manufacturing organizations.
Review laboratory investigation reports and recommend appropriate corrective and preventive actions.
Support the preparation of analytical sections for regulatory submissions, including method development, validation, and stability documentation.
Maintain technical records, method lifecycle documentation, review comments, and analytical change-control assessments.
Monitor developments in analytical chemistry, pharmaceutical stability science, and regulatory guidance.
Identify opportunities to improve analytical method reliability, data integrity, and documentation workflows.

Qualifications and Experience

Bachelor's degree in Pharmaceutical Chemistry, Analytical Chemistry, Chemistry, Pharmacy, Pharmaceutical Sciences, or a related discipline.
Master's degree or PhD in Analytical Chemistry, Pharmaceutical Analysis, or a related field is an advantage.
Significant experience in pharmaceutical analytical development, stability testing, analytical method validation, or quality control.
Strong understanding of stability-indicating analytical methods and their application in pharmaceutical development.
Practical knowledge of forced degradation studies and the evaluation of pharmaceutical degradation pathways.
Advanced understanding of HPLC, UPLC, GC, UV-visible spectroscopy, and other relevant analytical techniques.
Experience reviewing…