Research & Development Specialist – Analytical Methods for Sterile Pharma

About the role

The Analytical Research Specialist will lead the development, validation, and lifecycle management of analytical methods for sterile pharmaceutical products, including parenterals, ophthalmic solutions, and inhalation products. The role ensures compliance with global regulatory guidelines and supports technology transfer to quality control laboratories.

Key responsibilities

• Develop and optimize analytical methods for sterile drug products and APIs (assay, related substances) in line with ICH Q14.
• Establish stability‑indicating methods for parenteral, ophthalmic, and inhalation products.
• Perform extractables/leachables and adsorption studies for glass and polymer containers (LDPE, PP, COC, COP).
• Conduct method validation/verification according to ICH Q2(R2), USP <1225>, Ph. Eur., and SFDA requirements, preparing protocols, reports, statistical evaluations and lifecycle documentation.
• Test APIs, excipients, formulation trials, stability samples and pilot batch validations for sterile dosage forms.
• Design and interpret stability studies under ICH climatic zones (Zone IVb) and execute forced degradation studies (hydrolytic, oxidative, thermal, photolytic).
• Assess the impact of sterilization on critical quality attributes such as pH, potency, impurities and particulates.
• Transfer validated analytical methods to QC laboratories and prepare the analytical sections of e‑CDT dossiers.
• Ensure GxP compliance in all laboratory activities and provide OOS/OOT investigations.
• Flexibly cover extended hours, weekend duties and night shifts as required.

Required profile

• Bachelor’s degree in Pharmacy or Chemistry (Master’s degree is a plus).
• 3–7 years of experience in analytical method development and validation for sterile pharmaceutical products.
• Strong scientific and regulatory writing skills.
• Ability to work independently with a “can‑do” attitude.

Required skills

• Proficiency with High‑Performance Liquid Chromatography (HPLC).
• Experience using Gas Chromatography (GC).
• Knowledge of Inductively Coupled Plasma (ICP) techniques.
• Familiarity with atomic spectroscopy methods.