Research Scientist

We are hiring Research Scientists for the Chemical Research & Development (CRD) team at the RnD-1 level. The role requires a chemist with 27 years of hands-on process/route development experience in an API or pharmaceutical R&D environment.

Key Responsibilities

• Design, develop, and optimize synthetic routes and processes for APIs, intermediates, and KSMs from lab scale through pilot/plant scale-up.
• Independently execute process development experiments, ensuring robustness, reproducibility, cost-effectiveness, and yield/quality improvement.
• Prepare and review technical documentation required for regulatory submissions, including process descriptions, batch records, development reports, and CTD/DMF Module 3 sections.
• Support regulatory query (deficiency) responses in coordination with the Regulatory Affairs team, including generation of data and justifications for process/impurity-related queries.
• Conduct impurity profiling, route-of-degradation studies, and genotoxic impurity control strategy in collaboration with the ARD team.
• Ensure compliance with cGMP, safety, and environmental norms during all laboratory and scale-up activities.
• Coordinate with Analytical R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams for smooth technology transfer of developed processes.
• Maintain accurate and contemporaneous documentation of experiments in laboratory notebooks/ELN in line with data integrity requirements.
• Review literature and patents to design non-infringing, efficient, and scalable synthetic routes.
• Guide and mentor junior scientists/research associates within the team.

Required Skills & Competencies

• Strong fundamentals in organic synthesis, reaction mechanisms, and process chemistry.
• Prior experience working on projects that were filed with or reviewed by regulatory agencies (e.g., USFDA, EDQM, WHO-GMP, or equivalent) is essential.
• Working knowledge of ICH guidelines (Q3A/Q3B/Q3C/Q3D, M7) as applicable to process impurities and residual solvents.
• Hands-on experience with scale-up, technology transfer, and troubleshooting at pilot/plant level.
• Good understanding of cGMP documentation practices, data integrity, and safety protocols (process hazard evaluation).
• Ability to interpret analytical data (HPLC, GC, NMR, Mass Spec) in collaboration with ARD.
• Strong written and verbal communication skills for technical report writing and cross-functional coordination.
• Proactive, detail-oriented, and able to work independently as well as within a team.