About This Role
This role is for a qualified and experienced professional in an Analytical Development Laboratory (ADL) focusing on injectable and oral solid dosage (OSD) pharmaceutical formulations. The selected candidate will be responsible for analytical method development, optimization, validation, verification, transfer, and related analytical activities to support formulation development and product commercialization.
Responsibilities
- Develop, optimize, validate, verify, and transfer analytical methods for pharmaceutical formulations, including sterile injectables, tablets, and capsules
- Perform analytical testing, including assay, related substances, dissolution, content uniformity, and other applicable tests
- Develop and optimize analytical methods using HPLC, UV-Visible spectroscopy, and other relevant analytical instruments
- Conduct forced degradation studies and develop stability-indicating analytical methods, as applicable
- Prepare, execute, review, and maintain analytical method development protocols, validation reports, analytical procedures, and method transfer documents
- Perform analytical method validation in accordance with approved protocols and applicable ICH guidelines
- Support analytical evaluation of formulation development batches and stability studies
- Troubleshoot chromatographic issues, analytical discrepancies, method failures, and instrument-related problems
- Coordinate analytical method transfer to Quality Control and provide technical support during implementation
- Review analytical data, chromatograms, calculations, raw data, and laboratory records to ensure accuracy, traceability, and data integrity
- Ensure compliance with applicable GMP requirements, pharmacopoeial standards, SOPs, and laboratory safety practices
- Maintain analytical instruments, reference standards, reagents, and laboratory documentation
- Coordinate with Formulation Development, Quality Control, Quality Assurance, and Regulatory Affairs for analytical and product development activities
- Support preparation of analytical data and technical documentation for regulatory submissions, audits, and inspections
- Investigate analytical discrepancies and support deviation investigations, corrective and preventive actions (CAPA), and continuous improvement activities
- Guide junior team members and coordinate laboratory activities according to experience and designation
Requirements
- M.Pharm / B.Pharm / M.Sc. in Chemistry or a relevant pharmaceutical science discipline; Ph.D. preferred for senior-level candidates
- Hands-on experience in analytical method development and validation for pharmaceutical formulations
- Practical knowledge of HPLC, UV-Visible spectroscopy, and chromatographic data interpretation
