Research Scientist

Kimia Biosciences; Bhondsi; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Kimia Biosciences is seeking a Research Scientist for the Chemical Research & Development team at the CRD level to lead advanced process development for APIs and intermediates. The role requires 27 years of hands-on experience in API/R&D environments, focusing on scale-up, tech transfer, and robust process design.

You will design and optimize routes, compile regulatory documentation, and collaborate across Regulatory, QA, and Manufacturing teams while mentoring junior scientists.

Qualifications

• Strong fundamentals in organic synthesis, reaction mechanisms, and process chemistry.
• Experience with regulatory filings and agency reviews (USFDA, EDQM, WHO-GMP or equivalent).
• Familiarity with ICH guidelines (Q3A/Q3B/Q3C/Q3D, M7) for impurities and residual solvents.
• Hands-on experience with scale-up, technology transfer, and troubleshooting at pilot/plant level.
• Knowledge of cGMP documentation practices, data integrity, and safety protocols.

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.
• 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.

Skills

Organic synthesis

Reaction mechanisms

Process chemistry

cGMP documentation

Data integrity

Safety protocols

Analytical data interpretation

HPLC

GC

NMR

Mass Spectrometry

Tools

HPLC

GC

NMR

Mass Spectrometry

Job description

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.