Research And Development Specialist📣 إعلان

About the Role

Pharmaceutical Solutions Industry "PSI", located in Jiddah, Makkah, Saudi Arabia, is seeking a Research And Development Specialist to join our team on a full-time basis. This role is central to the development, validation, and lifecycle management of analytical methods for a range of sterile pharmaceutical products, including parenterals, ophthalmic solutions, and inhalation products.

Role Focus

The primary focus of this role involves the comprehensive management of analytical methods for sterile pharmaceutical products. This includes ensuring the robustness and reliability of methods used for parenterals, ophthalmic solutions, and inhalation products throughout their lifecycle, from development through validation and ongoing maintenance.

Core Responsibilities

• Develop and optimize analytical methods for sterile drug products and APIs (assay, related substances) in accordance with ICH Q14 guidelines.
• Establish stability-indicating methods for parenteral, ophthalmic, and inhalation products.
• Conduct extractables/leachables and adsorption studies for glass and polymer-based containers (LDPE, PP, COC, COP).
• Perform method validation and verification according to ICH Q2(R2), USP <1225>, Ph. Eur., and SFDA requirements.
• Prepare validation protocols and reports, including statistical evaluation and lifecycle documentation.
• Test API, excipients, formulation trials, stability samples, and pilot batch validation for sterile dosage forms.
• Design and interpret stability studies for sterile products under ICH climatic zones (Zone IVb).
• Conduct forced degradation studies under hydrolytic, oxidative, thermal, and photolytic conditions.
• Evaluate the impact of sterilization on product Critical Quality Attributes (CQAs) such as pH, potency, impurities, and particulates.
• Facilitate technology transfer of analytical methods to the Quality Control (QC) laboratory for sterile products.
• Prepare and revise the analytical part of e-CDT dossiers.
• Ensure adherence to GxP guidelines in all laboratory activities.

Required Experience and Expertise

• A minimum of 5 to 10 years of experience in research and development, specifically with analytical method development and validation for sterile pharmaceutical products.
• Proven ability to develop and optimize analytical methods (assay, related substances) compliant with ICH Q14.
• Demonstrated knowledge of regulatory guidelines including ICH Q2(R2), USP <1225>, Ph. Eur., and SFDA requirements.
• Strong understanding and practical application of GxP principles in laboratory operations.
• Experience in designing and interpreting stability studies and forced degradation studies.

Operational Demands

This full-time position requires a commitment to operational flexibility. The successful candidate must be prepared to cover extended working hours, weekend duties, and night shifts as operational requirements dictate, ensuring continuous support for critical projects and laboratory activities.

Work Location

This role is based in Jiddah, Makkah, Saudi Arabia, offering an opportunity to contribute to the pharmaceutical industry within a dedicated research and development environment.