Associate Researcher

Job Title : Research Associate – Analytical Development Laboratory (ADL)

Department : Research & Development (API Manufacturing)

Location : Dholka, Ahmedabad, Gujarat

Position Summary :

We are seeking a highly skilled and detail-oriented Research Associate – ADL to join our API R&D team. The selected candidate will be responsible for the development, validation, and transfer of analytical methods for Active Pharmaceutical Ingredients (APIs). The role plays a critical part in ensuring product quality, supporting process development, and facilitating regulatory compliance across the API lifecycle.

Key Responsibilities :

• Develop and validate analytical methods for raw materials, intermediates, and APIs using techniques such as HPLC, GC, UV, IR, KF, and titration.
• Support API process development teams by analyzing in-process samples, final products, and impurities.
• Characterize degradation products and impurities using advanced analytical tools (e.g., LC-MS, GC-MS, NMR – if available).
• Perform routine and non-routine analysis to support R&D, stability studies, and method transfer activities.
• Conduct analytical method transfers to QC and manufacturing sites (internal or external).
• Prepare and review analytical documentation, including method validation protocols, reports, SOPs, and COAs.
• Ensure adherence to GLP, cGMP, and data integrity standards during all analytical activities.
• Maintain laboratory instruments and troubleshoot minor issues to minimize downtime.
• Participate in OOS investigations, deviations, and CAPA implementations.
• Collaborate closely with cross-functional teams including process chemistry, regulatory affairs, and quality assurance.

Qualifications :

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Skills Required

Hplc, Uv, Nmr, titration , Ir, Kf, Gc