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Posted a day ago
Research Scientist - Analytical
SPI PharmaResearch Scientist - Analytical
Requirements
M.Pharm or M.Sc. Chemistry, Analytical method development experience, Proficiency in HPLC and UPLC, Knowledge of GLP/GMP and ICH guidelines
Skills
HPLCUPLCGLPGMP
About the role
Responsibilities
- Execute laboratory activities adhering to GLP/GMP guidelines and internal SOPs
- Develop, validate, and implement analytical methods for drug substances, impurities, and finished dosage forms
- Perform routine testing including Assay, Dissolution, Related Substances, and Content Uniformity
- Conduct stability studies in accordance with ICH guidelines
- Troubleshoot analytical and instrumental issues
- Maintain analytical instruments such as HPLC, UPLC, UV-Vis, FTIR, and Dissolution Apparatus
- Maintain accurate lab notebooks and reports following Good Documentation Practices (GDP)
- Support regulatory submissions with necessary analytical data
- Collaborate with formulation R&D, quality control, and manufacturing teams
Requirements
- Master’s degree in Pharmaceutical Sciences (M.Pharm) or M.Sc. in Chemistry
- Practical experience in analytical method development and validation
- Proficiency with HPLC, UPLC, GC-MS, LC-MS/MS, ICP-MS, UV-Vis, FTIR, XRPD, DSC, and TGA
- Understanding of pre-formulation and stability study protocols
- Familiarity with ICH guidelines, FDA/EMA requirements, and GLP/GMP compliance
- Experience with soft gelatin capsules and solid oral dosage forms is an advantage
About the Company
SPI Pharma, part of Associated British Foods plc, is a global leader in providing innovative solutions to the pharmaceutical and nutraceutical industries, specializing in high-quality excipients, antacid actives, and drug delivery systems.
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SPI Pharma · Bangalore
