Scientist-Analytical R & D - API

Key Responsibilities

• Method Development and Validation

  : Conduct analytical method development, verification, validation, and transfers. This includes methods for related substances, assay, residual solvents, and cleaning procedures.

• Analytical Support

  : Provide analytical support to process development teams. This involves analyzing samples using instruments such as

  HPLC (High-Performance Liquid Chromatography)

  ,

  GC (Gas Chromatography)

  ,

  IR (Infrared Spectroscopy)

  ,

  KF Titrator (Karl Fischer Titrator)

  ,

  SOR (Specific Optical Rotation)

  ,

  ROI (Residue on Ignition)

  , and

  LOD (Loss on Drying)

  .

• Documentation and Compliance

  : Ensure the timely completion of all analysis, documentation, data reviews, and report delivery. This includes preparing and maintaining reference and working standards. The candidate must have a solid understanding of

  SOPs (Standard Operating Procedures)

  ,

  STPs (Standard Test Procedures)

  ,

  ICH Guidelines (International Council for Harmonisation)

  , and various Pharmacopoeias. They must strictly adhere to

  Good Laboratory Practices (GLP)

  and safety protocols.

• Operational Support

  : Provide need-based support to manufacturing facilities for analysis or investigation.

• Instrument Maintenance

  : Maintain and calibrate all laboratory instruments within the specified timelines.

• Technology Transfer

  : Timely complete technology transfer activities, including holding studies and method summaries. The role also involves preparing specifications, methods of analysis, validation protocols, and reports.

• Project and Document Review

  : Review project-related documents, such as specifications, methods of analysis, protocols, reports, and electronic lab notebook (ELN) experiments. They will also review instrument calibration sequences.

• Administrative Tasks

  : Raise

  CCF (Change Control Form)

  ,

  Incident

  ,

  RGP (Returnable Gate Pass)

  , and

  NRGP (Non-Returnable Gate Pass)

  as needed. The candidate may also be assigned other periodic activities.

Required Skills and Qualifications

• A

  Bachelor's or Master's degree in Chemistry

  ,

  Analytical Chemistry

  , or a related field.
• Proven experience in

  analytical method development and validation

  .
• Proficiency in operating and troubleshooting a range of analytical instruments, especially

  HPLC and GC

  .