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

About the Role

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.

Key Responsibilities

• 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.

Qualifications and Experience

• Bachelor's degree in Pharmaceutical Sciences, Analytical Chemistry, Chemistry, Pharmaceutical Analysis, or a related scientific discipline.
• A 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 method principles and pharmaceutical degradation chemistry.
• Practical knowledge of HPLC, UHPLC, GC, UV spectroscopy, and other relevant analytical techniques.
• Experience reviewing forced degradation studies and evaluating degradation products and impurity profiles.
• Understanding of analytical method validation characteristics, including specificity, accuracy, precision, linearity, range, and robustness.
• Familiarity with ICH Q1, Q2, Q3, and other relevant pharmaceutical quality guidance.
• Knowledge of applicable pharmacopoeial requirements and pharmaceutical quality management principles.
• Experience reviewing chromatographic data, analytical validation reports, stability protocols, and technical investigations.
• Understanding of data integrity, controlled documentation, deviation management, and change control principles.
• Familiarity with laboratory information management systems, electronic laboratory notebooks, and chromatography data systems.
• Strong scientific reasoning, analytical review, and technical writing skills.
• Excellent attention to detail and ability to identify inconsistencies in complex analytical datasets.
• Strong communication and cross-functional coordination abilities.
• Ability to work independently and collaborate effectively with laboratory and regulatory teams in a fully remote environment.

What We Offer

• Fully remote working arrangement within the stated UAE-based role framework.
• Opportunity to support advanced pharmaceutical analytical development and stability assessment activities.
• Collaboration with analytical scientists, quality professionals, and regulatory specialists.
• A professional environment focused on scientific rigor, data integrity, and pharmaceutical quality.
• Opportunities for continued development in analytical method validation and pharmaceutical stability science.

How to Apply

Interested candidates should submit an updated CV highlighting their pharmaceutical analytical experience, stability-indicating method expertise, chromatographic data review capabilities, and knowledge of analytical method validation.

Application Subject: Application – Senior Drug Stability-Indicating Method Specialist (UAE Remote)

• Candidates should confirm applicable employment arrangements, residency requirements, and work authorization before accepting an offer. This is a fully remote technical review and coordination role. Physical sample preparation, chemical handling, forced degradation experiments, laboratory testing, instrument operation, calibration, and method execution must be performed by qualified local laboratory personnel in appropriately equipped facilities. Clinical, quality, regulatory, and formal method approvals or sign-offs requiring professional authorization must be completed by appropriately qualified and authorized personnel.