Scientist / Senior Scientist

Job Title: Scientist / Sr. Scientist API R&D

Department: Research & Development

Location: Kolkata

Key Responsibilities:

• Analytical Method Development:

  Develop and validate robust analytical methods (HPLC, GC, LC-MS, UV, FTIR, etc.) for quantification, purity, stability, and impurity profiling of APIs (maintaining GLP)

• Method Validation and Verification:

  Conducting studies to confirm that the developed methods are suitable for their intended purpose, meeting parameters like specificity, accuracy, precision, linearity, and ruggedness, Prepare and review technical documentation, including method development reports, validation protocols/reports, and regulatory submission documents.

• Method Transfer:

  Facilitating the successful transfer of analytical methods to quality control or production laboratories, ensuring reproducibility across different instruments and environments.

• Stability Studies:

  Implementing and managing API stability programs to monitor how products perform under various environmental conditions over time, ensuring continued compliance with quality standards.

• Regulatory and Quality Support:

  Providing analytical data and reports in support of regulatory filings and ongoing quality assurance requirements.

• Troubleshooting and Problem Solving:

  Using analytical expertise and state-of-the-art equipment to resolve issues, such as product failures or abnormal impurity profiles, quickly and accurately.

• Instrument Calibration and Maintenance:

  Ensuring analytical instruments are properly maintained and calibrated for reliable and reproducible results.

• Reference Standard Management:

  Handling selection, qualification, and maintenance of reference standards for ongoing quality control.

• Routine analysis work

Qualifications & Skills:

• M.Sc. / M.Pharm / B.Tech/M.Tech

  in Analytical Chemistry, Pharmaceutical Chemistry, or related discipline.

• 3–8 years of relevant experience in a pharmaceutical R&D or CRO environment.

• Hands-on expertise in analytical instruments (HPLC, GC, UV-Vis/IR etc.).

• Sound understanding of ICH, USP/EP, and regulatory requirements.

• Proficient in data analysis, interpretation, and documentation.

• Strong problem-solving and communication skills; ability to work in cross-functional teams.