Research And Development Specialist - Analytical

About the Role

We are seeking a dedicated Analytical Research Specialist to drive the development, validation, and ongoing management of analytical methodologies for sterile pharmaceutical products. This includes parenterals, ophthalmic formulations, and inhalation drug products.

Key Responsibilities

• Create and refine analytical test methods targeting sterile drug substances and active pharmaceutical ingredients, focusing on assays and related substances aligned with ICH Q14 guidelines.
• Develop stability-indicating analytical techniques specifically for parenteral, ophthalmic, and inhalation formulations.
• Perform extractables, leachables, and adsorption evaluations for packaging materials including glass and polymers such as LDPE, PP, COC, and COP.
• Validate and verify analytical procedures in compliance with ICH Q2(R2), USP <1225>, European Pharmacopoeia, and Saudi FDA standards.
• Draft and execute validation protocols, compile comprehensive reports, conduct statistical analysis, and manage the lifecycle documentation of analytical methods.
• Carry out testing of APIs, excipients, formulation trials, stability samples, and pilot batch validations specifically for sterile dosage forms.
• Plan and analyze stability studies for sterile products under various ICH climatic zones, including Zone IVb.
• Implement forced degradation studies under hydrolytic, oxidative, thermal, and photolytic stress conditions to assess product stability.
• Assess the effects of sterilization processes on critical quality attributes including pH, potency, impurities, and particulate matter.
• Manage technology transfer of developed analytical methods to quality control laboratories focused on sterile products.
• Prepare and update the analytical sections of electronic Common Technical Document (e-CTD) dossiers.
• Ensure strict adherence to Good Laboratory Practices (GxP) throughout laboratory operations.
• Be adaptable to work extended hours, night shifts, and weekends when operational requirements demand.

Qualifications & Experience

• Bachelor's degree in Pharmacy or Chemistry; advanced degrees considered favorable.
• Minimum of 3 to 7 years of experience in pharmaceutical analytical research and development.

Required Skills

• Proficient in operating and interpreting data from HPLC, GC, ICP, and atomic spectroscopy instruments.
• Strong expertise in scientific and regulatory documentation and report writing.
• Competence in out-of-specification (OOS) and out-of-trend (OOT) investigations.
• Highly motivated with a proactive and solution-oriented mindset.

Additional Information

This full-time, onsite position is based in Jiddah, Makkah, Saudi Arabia. Candidates should be prepared to comply with shift variations and extended working schedules as needed to meet operational demands.