JOB DETAILS:

Job Summary:

The Analytical Method Development Specialist is responsible for developing, optimizing, and validating analytical methods for the identification, quantification, and characterization of pharmaceutical raw materials, intermediates, and finished products. The role ensures all methods meet regulatory standards in line with ICH Q2(R2) guidelines, are robust, reproducible, and suitable for routine use in quality control and regulatory submissions. This specialist will work closely with formulation scientists, quality assurance, regulatory affairs, and production teams to support product development, method transfers, and dossier compilation. The ideal candidate must have strong expertise in chromatographic and spectroscopic techniques and be proficient in GMP and GLP environments.

Key Duties and Responsibilities:

1. Design and execute development and validation of analytical methods including HPLC, UV-Vis, FTIR, GC and dissolution techniques.
2. Prepare and execute method development and validation protocols and reports in compliance with ICH guidelines.
3. Optimize analytical parameters to ensure method accuracy, precision, specificity, linearity, robustness and system suitability.
4. Conduct forced degradation studies and stability-indicating method development for regulatory filing.
5. Troubleshoot analytical challenges and refine existing methods to improve performance and efficiency.
6. Coordinate with QC and QA teams to facilitate method transfer and training for routine use.
7. Maintain accurate records and raw data in compliance with ALCOA+ data integrity principles.
8. Support CTD Module 3 (P.5 and S.4) preparation for product registration.
9. Ensure analytical instrumentation is properly qualified, calibrated, and maintained.
10. Contribute to audit readiness, regulatory inspections, and continuous improvement initiatives.

Academic Qualifications:
Bachelor’s degree in Analytical Chemistry, Industrial Chemistry, Pharmacy or a related scientific field. A Master’s degree in Analytical Chemistry or Pharmaceutical Analysis is an added advantage.

Experience and Competencies:

1. Minimum of 4–6 years of experience in analytical method development within a pharmaceutical R&D or QC environment.
2. Proficiency in analytical instruments such as HPLC, UV, FTIR, GC and dissolution testers.
3. Strong understanding of ICH Q2(R2), USP/BP/Ph. Eur. compendial methods, and validation life cycle.
4. Hands-on experience in handling stability studies and impurity profiling.
5. Familiarity with Good Laboratory Practices (GLP), GMP documentation, and regulatory submission requirements.
6. Excellent problem-solving, technical writing, and collaborative communication skills.