Senior Drug Stability Indicating Method Specialist

Therapy Essence; Abu Dhabi; A distancia; AED 800.000 - 1.200.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote work

Competitive compensation

Career progression

Descripción de la vacante

Therapy Essence is seeking a Senior Drug Stability-Indicating Method Specialist to develop, optimize, and validate stability-indicating analytical methods for drug substances and products. This fully remote role requires expertise in forced degradation, chromatographic techniques, and regulatory documentation, with collaboration across labs and QA teams.

The candidate will review degradation studies, interpret analytical data, and ensure methods meet ICH, GMP, and pharmacopoeial expectations

Formación

• Bachelor's or master's in Pharmaceutical Sciences or related field.
• Significant experience in analytical method development and stability testing.
• Strong understanding of forced degradation studies and related impurity assessment.
• Experience with HPLC/UPLC/GC and spectroscopy.
• Familiarity with ICH guidelines and GMP/GLP principles.

Responsabilidades

• Develop, review, and optimize stability-indicating methods for APIs and products.
• Evaluate procedures to distinguish active ingredients from degradants and impurities.
• Support forced degradation study protocols under stress conditions.
• Review degradation pathways and impurity formation with analytical data.
• Oversee method transfer and documentation for regulatory submissions.
• Maintain data integrity and controlled documentation across projects.
• Provide remote guidance and training to lab teams.

Conocimientos

Analytical method development

Forced degradation studies

Regulatory documentation

Chromatographic techniques

Data interpretation

Regulatory compliance

Remote collaboration

Technical writing

Educación

Bachelor's or Master's in Pharmaceutical Sciences/Analytical Chemistry

Herramientas

HPLC

UPLC

GC

UV-Visible spectroscopy

Descripción del empleo

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 Analysis, or a related scientific discipline.
• Significant experience in pharmaceutical analytical development, stability testing, analytical method validation, or quality control.
• Strong understanding of stability-indicating analytical methods and their role in pharmaceutical product development.
• Practical knowledge of forced degradation studies and the assessment of degradation products and impurity profiles.
• Experience with HPLC, UPLC, GC, UV-visible spectroscopy, or other relevant analytical technologies.
• Strong knowledge of analytical method validation principles and applicable ICH guidelines, including ICH Q2(R2) and ICH Q14.
• Familiarity with pharmaceutical stability requirements and ICH Q1 guidance, as applicable to the product and study.
• Experience reviewing analytical data, chromatograms, system suitability results, and method performance characteristics.
• Understanding of pharmaceutical impurities, degradation mechanisms, and analytical specificity.
• Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and data integrity principles relevant to assigned activities.
• Experience preparing and reviewing analytical method development, validation, and stability documentation.
• Familiarity with electronic laboratory systems, chromatography data systems, and controlled document management platforms.
• Strong scientific writing, data interpretation, and technical problem-solving skills.
• High attention to detail and the ability to manage multiple analytical projects and regulatory deadlines.
• Excellent communication skills and the ability to coordinate effectively with multidisciplinary teams in a remote environment.

What We Offer

• A fully remote, work-from-home arrangement.
• Competitive compensation based on experience and qualifications.
• Opportunities to contribute to pharmaceutical analytical development and product quality initiatives.
• Collaboration with pharmaceutical scientists, laboratory teams, quality professionals, and regulatory specialists.
• Professional development and opportunities for career progression.

Candidates should confirm applicable employment arrangements, residency requirements, and work authorization before accepting an offer. This position is designed for remote technical oversight, analytical data review, method development support, and documentation activities. Laboratory experiments, instrument operation, sample handling, and physical testing must be performed by appropriately qualified personnel at authorized laboratory facilities. Formal regulatory submissions and quality approvals must be completed or authorized by appropriately designated personnel in accordance with applicable requirements.