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

We are seeking an experienced Senior Drug Stability-Indicating Method Specialist to lead the development, validation, optimization, and lifecycle management of analytical methods used to assess pharmaceutical drug stability. The role focuses on ensuring that analytical procedures reliably distinguish active pharmaceutical ingredients from degradation products, impurities, and other potential interferences. Working remotely, the specialist will provide technical guidance, review analytical data, assess method performance, and support pharmaceutical quality and regulatory documentation in accordance with applicable industry standards and regulatory expectations.

Key Responsibilities

• Lead the development and optimization of stability-indicating analytical methods for pharmaceutical active ingredients and finished drug products.
• Design analytical approaches capable of separating and quantifying active ingredients, degradation products, process impurities, and excipients.
• Develop and assess forced degradation studies under relevant stress conditions, including hydrolysis, oxidation, heat, humidity, and photolysis.
• Evaluate degradation pathways and support the identification and characterization of potential degradation products.
• Oversee method validation activities in accordance with applicable ICH guidelines and internal quality requirements.
• Review method parameters, including specificity, accuracy, precision, linearity, range, robustness, and detection and quantitation limits.
• Assess chromatographic techniques, including HPLC, UPLC, and other suitable analytical platforms.
• Review analytical data, chromatograms, system suitability results, and method performance trends.
• Investigate atypical results, analytical discrepancies, out-of-specification results, and out-of-trend findings.
• Provide technical recommendations for improving method selectivity, sensitivity, reproducibility, and operational efficiency.
• Support stability study protocols, analytical testing strategies, and product shelf-life assessment activities.
• Evaluate analytical method transfer documentation and provide remote technical guidance during transfer activities.
• Review analytical procedures, validation protocols, reports, and technical documentation for accuracy and completeness.
• Collaborate with formulation development, analytical development, quality control, quality assurance, and regulatory affairs teams.
• Assess the impact of formulation, manufacturing, packaging, and storage changes on analytical method performance.
• Support investigations into degradation mechanisms and potential interactions between drug substances, excipients, and packaging materials.
• Monitor relevant scientific developments, analytical technologies, and regulatory guidance affecting stability-indicating methods.
• Contribute to continuous improvement initiatives involving analytical method lifecycle management and laboratory data quality.

Qualifications and Experience

• Bachelor's or master's degree in Analytical Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, or a related discipline.
• Extensive experience in pharmaceutical analytical development, stability testing, or analytical method validation.
• Strong knowledge of stability-indicating method development and degradation product assessment.
• Practical understanding of forced degradation study design and interpretation.
• Advanced knowledge of chromatographic techniques, particularly HPLC and UPLC.
• Familiarity with analytical techniques such as UV-Vis spectroscopy, LC-MS, GC, and related instrumentation.
• Demonstrated understanding of ICH stability and analytical validation guidelines, including relevant principles of ICH Q1 and Q2.
• Experience evaluating method specificity, accuracy, precision, linearity, robustness, and sensitivity.
• Ability to interpret complex chromatographic data and investigate unexpected analytical results.
• Knowledge of pharmaceutical impurities, degradation pathways, and analytical method troubleshooting.
• Experience reviewing analytical validation protocols, reports, stability reports, and controlled laboratory documentation.
• Understanding of pharmaceutical quality systems, good manufacturing practice (GMP), and good documentation practices.
• Familiarity with analytical method transfer, lifecycle management, and change control processes.
• Strong technical writing, data interpretation, and scientific problem-solving skills.
• Ability to coordinate effectively with cross-functional teams in a remote working environment.
• High attention to detail and commitment to data integrity, traceability, and quality standards.

What We Offer

• Fully remote working arrangement within the UAE employment framework, subject to applicable eligibility and authorization requirements.
• Opportunity to contribute to pharmaceutical analytical development and product quality initiatives.
• Collaboration with multidisciplinary pharmaceutical, laboratory, and regulatory teams.
• Professional development in analytical technologies, stability science, and pharmaceutical quality practices.
• A technically challenging role with opportunities to influence analytical strategy and method performance.

How to Apply

Interested candidates should submit an updated CV highlighting their pharmaceutical analytical development experience, stability-indicating method expertise, method validation background, and relevant technical qualifications.

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

• Important Note: This is a remote technical and analytical oversight position. Physical laboratory testing, instrument operation, sample handling, and experimental activities must be performed by appropriately qualified personnel at authorized facilities. Any regulated laboratory approvals, formal quality decisions, or regulatory submissions must be completed by personnel with the required professional authorization. Candidates should confirm applicable employment arrangements, residency requirements, and work authorization before accepting an offer.