39 Intas Pharmaceuticals Jobs

Role & responsibilities

Reverse Engineering of Formulations:

• Perform reverse engineering of reference-listed drugs (RLDs) and identify composition, excipients, and active ingredients.
• Utilize advanced analytical techniques for component identification and quantification.

Analytical Method Development & Validation:

• Develop and validate HPLC, UPLC, GC, LC-MS, FTIR, UV, NMR, XRD, and DSC methods for comparative studies.
• Characterize excipients, degradation products, and impurities in formulations.

Comparative Dissolution & Physicochemical Characterization:

• Conduct comparative dissolution profiling with RLD as per regulatory guidelines.
• Study particle size, polymorphism, stability, and compatibility of drug formulations.

Regulatory Compliance & Documentation:

• Prepare analytical reports, method validation protocols, and regulatory documents for ANDA, USFDA, MHRA, EU-GMP submissions.
• Ensure compliance with ICH, USP, EP, JP, and WHO guidelines.

Technology Transfer & Troubleshooting:

• Support technology transfer for scale-up and commercialization.
• Assist in troubleshooting analytical challenges during formulation development.

Key Skills & Competencies:

✅Expertise in HPLC /UPLC / GC / LC-MS / FTIR / NMR/ XRD/ DSC
✅ Knowledge of polymorphism, solubility, permeability, and excipient compatibility
✅ Experience in reverse engineering & impurity profiling
✅ Strong understanding of ICH Q2 (R1), USFDA, and regulatory guidelines
✅ Hands-on experience in GMP, GLP, and stability studies

Preferred candidate profile

M. Pharmacy / M.Sc (Analytical Chemistry / Pharmaceutical Chemistry / Organic Chemistry)

Perks and benefits

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