Senior Drug Stability-Indicating Method Specialist (Remote, UAE)
TEAM - Total Engine Asset Management
وصف الوظيفة
About the role
A fully remote, 100% work-from-home position based in the UAE seeks 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 role supports pharmaceutical development and quality teams through analytical data review, method development strategy, technical documentation and virtual coordination with qualified laboratory personnel. Physical laboratory work, formal quality decisions and regulatory submissions must be carried out by appropriately qualified local staff.
Key responsibilities
- Lead the scientific strategy for developing and evaluating stability-indicating methods for drug substances and products
- Review method development plans, forced degradation studies and method validation protocols, including HPLC, UPLC and GC procedures
- Evaluate specificity, selectivity, accuracy, precision, robustness and system suitability; assess method transfer and comparability results
- Interpret stability study data and impurity profiles, and investigate out-of-specification results and analytical deviations
- Support shelf-life, retest periods and stability specifications, and prepare analytical sections for regulatory submissions
- Coordinate remotely with laboratories, quality control teams, CROs and CMOs, and maintain technical records and change-control assessments
Required profile
- Bachelor's degree in Pharmaceutical Chemistry, Analytical Chemistry, Chemistry, Pharmacy or Pharmaceutical Sciences; Master's or PhD is an advantage
- Significant experience in pharmaceutical analytical development, stability testing, method validation or quality control
- Strong scientific writing, technical review and problem-solving skills
Required skills
- HPLC, UPLC, GC, UV-visible spectroscopy and chromatographic separation
- ICH stability and analytical validation guidelines (Q1, Q2) and pharmacopoeial standards
- Impurity profiling, forced degradation studies and stability data interpretation
- Quality management systems, change control, CAPA and data integrity
- Proficiency reviewing chromatographic data systems and laboratory information management systems
What we offer
- 100% remote working arrangement within the UAE employment context
- Exposure to advanced analytical methodologies and international quality standards
- Professional development in analytical chemistry, stability science and regulatory documentation
To apply, submit an updated CV via the application form, stating the subject "Application - Senior Drug Stability-Indicating Method Specialist (UAE Remote)".
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TEAM - Total Engine Asset Management
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