Senior Drug Stability Indicating Method Specialist

Prestige African Art; Abu Dhabi; Remote; AED 350,000 - 580,000; Full time

Benefits offered by this job

Fully remote work

Professional development

Job summary

Prestige African Art is seeking a Senior Drug Stability-Indicating Method Specialist to review and validate analytical methods for stability, degradation, and impurity control across pharmaceutical products. This fully remote UAE-based role collaborates with analytics development, QA, and regulatory teams to ensure scientific soundness and regulatory readiness.

You will evaluate HPLC/UHPLC methods, forced degradation data, and validation characteristics, support method transfer, and contribute

Qualifications

• Strong knowledge of stability-indicating method principles and degradation chemistry.
• Experience with HPLC/UHPLC, GC, UV spectroscopy, and data interpretation.
• Familiarity with ICH Q1, Q2, Q3 and pharmacopoeial requirements.

Responsibilities

• Review methods distinguishing APIs from degradants, impurities, and excipients.
• Assess stability-indicating method suitability for substances and products.
• Review forced degradation study protocols and results.
• Evaluate chromatographic data from stress conditions (acid/base/oxidation/heat/humidity/photolysis).
• Review chromatography methods (HPLC/UHPLC) and validation data.
• Assess validation characteristics: specificity, accuracy, precision, linearity, range, robustness.
• Examine impurity profiles and degradation pathways.
• Assist with method transfer and cross-lab documentation.
• Coordinate with scientists to resolve technical questions.
• Support regulatory documentation related to analytical methods and stability.

Skills

Analytical thinking

Technical writing

Cross-functional coordination

Independent work

Education

Bachelor's degree in Pharmaceutical Sciences or related

Master's or PhD in Analytical Chemistry/Pharmaceutical Analysis (advantage)

Tools

HPLC

UHPLC

GC

UV spectroscopy

LIMS

ELN

Job description

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.