Analytical R&D Scientist

Job Overview

We are seeking a highly motivated Analytical Research & Development Scientist with a strong background in analytical method development and pharmaceutical analysis. This role involves developing, validating, and transferring analytical methods for both drug substance (API) and drug product (injectables). The successful candidate will play a key role in supporting formulation development, stability programs, and regulatory submissions.

Key Responsibilities

Analytical Method Development & Validation

• Design, develop, and validate analytical test methods for drug substances (APIs) and finished injectable products, ensuring accuracy, specificity, precision, and robustness.
• Develop impurity profiling, stability-indicating methods, and dissolution or release methods where applicable.
• Support analytical method transfer to Quality Control or contract testing laboratories.

Characterization & Testing

• Characterize physical and chemical properties of drug substances and formulations using advanced analytical techniques (e.g., UPLC, GC, GC-MS, LC-MS, SEC-MALLS, Zetasizer, Ion Chromatography).
• Conduct compatibility, extractables/leachables, and degradation studies.
• Execute stability studies in compliance with ICH guidelines, interpret data trends, and support specification setting.

Instrumentation & Troubleshooting

• Operate and maintain analytical instruments such as UPLC, HPLC, GC, GC-MS, SEC-MALLS, UV-Vis, FTIR, Zetasizer, and other relevant technologies.
• Troubleshoot analytical issues and optimize existing methods for better performance and reproducibility.

Collaboration & Documentation

• Work closely with Formulation Development, Quality Assurance, and Manufacturing teams to support all stages of product development.
• Prepare and review analytical method validation protocols, reports, stability summaries, and regulatory documentation per USFDA and ICH standards.
• Ensure accurate and compliant documentation in laboratory notebooks and electronic systems.

Continuous Improvement

• Stay current with emerging analytical technologies, regulatory trends, and scientific literature.
• Recommend and implement analytical improvements to enhance laboratory efficiency and data quality.

Qualifications

• Master’s or PhD in Pharmaceutical Sciences, Analytical Chemistry, or related field.
• 1–5 years of experience in pharmaceutical analytical method development (preferred, but recent graduates with strong research experience are encouraged to apply).
• Hands-on experience with UPLC/HPLC, GC, GC-MS, SEC-MALLS, Ion Chromatography, and particle size analysis (Zetasizer).
• Strong understanding of analytical validation per ICH Q2(R2) and USFDA requirements.
• Knowledge of stability studies, impurity profiling, and regulatory documentation practices.
• Excellent communication, problem-solving, and organizational skills.
• Ability to work collaboratively in a dynamic, cross-functional environment.

What We Offer

• Hands-on training in state-of-the-art analytical technologies.
• Opportunities to work on novel injectable product development projects from concept to regulatory submission.
• A collaborative and innovative workplace culture with mentorship from experienced scientists.
• Competitive compensation and growth opportunities within a fast-expanding organization.