Senior Drug Stability Indicating Method Specialist Job Abu Dhabi 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 develop, optimize, validate, and oversee analytical methods used to assess pharmaceutical product stability, potency, purity, and degradation. The successful candidate will support pharmaceutical development and quality programs by evaluating stability-indicating analytical procedures, reviewing degradation studies, interpreting analytical data, and ensuring that methods meet applicable regulatory and scientific standards.

This fully remote role is suited to a pharmaceutical analytical science professional with strong expertise in analytical method development, forced degradation studies, stability testing, chromatographic techniques, and regulatory documentation. The specialist will collaborate remotely with analytical laboratories, quality assurance teams, formulation scientists, contract research organizations, and regulatory affairs professionals.

Key Responsibilities

Develop, review, and optimize stability-indicating analytical methods for pharmaceutical drug substances and drug products.
Evaluate analytical procedures for their ability to distinguish active pharmaceutical ingredients from degradation products, impurities, and excipients.
Support the development and review of forced degradation study protocols under appropriate stress conditions.
Assess degradation pathways and review analytical evidence relating to product stability and impurity formation.
Review analytical methods using techniques such as high-performance liquid chromatography (HPLC), ultra-performance liquid chromatography (UPLC), gas chromatography (GC), and spectroscopic analysis, as applicable.
Establish and evaluate method performance characteristics, including specificity, accuracy, precision, linearity, range, robustness, and detection and quantitation limits where applicable.
Coordinate analytical method validation and verification activities in accordance with approved protocols.
Review stability study data for drug substances, finished pharmaceutical products, and relevant intermediates.
Evaluate chromatograms, assay results, impurity profiles, degradation trends, and analytical system suitability results.
Investigate atypical analytical results, unexpected degradation patterns, and potential out-of-specification or out-of-trend findings.
Collaborate with analytical development, formulation development, quality control, and quality assurance teams to resolve technical issues.
Review analytical method transfer documentation and support transfer activities between laboratories.
Prepare and review analytical development reports, method validation reports, forced degradation reports, and stability study summaries.
Ensure analytical procedures and associated documentation align with applicable ICH guidelines, pharmacopoeial requirements, and relevant regulatory expectations.
Support the preparation of analytical sections for regulatory submissions, including applicable Chemistry, Manufacturing, and Controls (CMC) documentation.
Maintain controlled documentation, data integrity, traceability, and version management throughout analytical development activities.
Assess opportunities to improve analytical methods, laboratory workflows, and data review processes.
Provide technical guidance to laboratory personnel and external testing partners through remote meetings, documentation reviews, and training sessions.

Qualifications and Experience

Bachelor's or master's degree in Pharmaceutical Sciences, Analytical Chemistry, Chemistry, Pharmaceutical…