Senior Drug Stability Indicating Method Specialist

TEAM - Total Engine Asset Management; Abu Dhabi; Remote; AED 350,000 - 550,000; Full time

Benefits offered by this job

100% remote work

Job summary

TEAM - Total Engine Asset Management is seeking a Senior Drug Stability-Indicating Method Specialist in a fully remote capacity. You will lead method development, validation, and lifecycle management for stability-indicating analytics, including forced degradation studies and impurity profiling, while coordinating with global labs and QA teams.

The ideal candidate has deep chromatographic expertise (HPLC/UPLC/GC), strong regulatory knowledge (ICH/Q1/Q2), and a track record in pharmaceutical

Qualifications

• Bachelor's degree in Pharmaceutical Chemistry or related field.
• Master's or PhD in Analytical Chemistry or Pharmaceutical Analysis is advantageous.
• Strong experience in pharmaceutical analytical development and stability testing.

Responsibilities

• Lead strategy for developing stability-indicating methods for drug substances and products.
• Review method development plans and ensure suitability for degradation products.
• Provide guidance on forced degradation studies under stress conditions.
• Assess method performance, including accuracy, precision, and robustness.
• Review validation, transfer, and chromatographic data for stability investigations.
• Coordinate remotely with labs and CRO/CMO partners.

Skills

Analytical Chemistry

Stability Methods

Chromatography

Regulatory Knowledge

Technical Writing

Remote Coordination

Education

Bachelor's in Pharmaceutical/Analytical Chemistry

Master's/PhD in Analytical Chemistry

Tools

HPLC

UPLC

GC

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

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 analytical method development, validation, verification, and transfer activities.
• Knowledge of impurity profiling, degradation product characterization, and chromatographic separation principles.
• Familiarity with ICH stability and analytical validation guidelines, including relevant Q1 and Q2 guidance.
• Understanding of applicable pharmacopoeial standards and pharmaceutical quality requirements.
• Experience interpreting stability data and assessing analytical trends across different storage conditions.
• Knowledge of system suitability, analytical specificity, robustness, accuracy, precision, and detection limits.
• Experience investigating out-of-specification results, out-of-trend results, analytical deviations, and laboratory discrepancies.
• Familiarity with pharmaceutical quality management systems, change control, CAPA, and data integrity principles.
• Experience reviewing technical reports, analytical protocols, validation packages, and regulatory documentation.
• Proficiency in reviewing chromatographic data systems and laboratory information management systems.
• Strong scientific writing, technical review, and problem-solving skills.
• Ability to coordinate analytical projects and provide technical guidance in a fully remote environment.

What We Offer

• A 100% remote working arrangement within the UAE employment context.
• Opportunities to contribute to pharmaceutical analytical development and product stability programs.
• Exposure to advanced analytical methodologies and international pharmaceutical quality standards.
• Professional development in analytical chemistry, pharmaceutical stability science, and regulatory documentation.
• A collaborative environment focused on scientific accuracy, data integrity, and continuous improvement.