Chemist / Officer - Research & Development

Job Description:

Key Responsibilities

• Process Development:

  • Design and execute multi-step organic synthesis experiments to develop new and innovative routes for API synthesis.

  • Conduct literature searches and patent reviews to identify non-infringing and commercially viable synthesis routes.

  • Optimize reaction parameters such as temperature, pressure, time, and solvent to improve yield, purity, and reduce costs.

• Technology Transfer:

  • Prepare and document process development reports and technology transfer documents (TTDs) for seamless scale-up.

  • Collaborate with pilot plant and manufacturing teams to successfully transfer developed processes.

  • Provide technical support and troubleshoot issues during scale-up and commercial production batches.

• Analytical and Data Management:

  • Utilize and interpret analytical data from instruments like HPLC, GC, NMR, Mass Spectrometry, and IR to monitor reactions and characterize products.

  • Ensure all experimental data and observations are meticulously recorded in a laboratory notebook, maintaining Good Laboratory Practices (GLP).

  • Compile stability data and other technical documents required for regulatory filings (e.g., Drug Master Files or DMFs).

• Impurity Profiling:

  • Identify, synthesize, and characterize impurities and degradation products to ensure product quality and regulatory compliance.

  • Conduct forced degradation studies to understand the stability profile of APIs.

• Collaboration & Communication:

  • Work closely with cross-functional teams including Analytical R&D (AR&D), Quality Assurance (QA), Quality Control (QC), and Regulatory Affairs.

  • Communicate project progress, challenges, and results to the R&D Manager and other stakeholders.

  • Mentor junior team members and contribute to a positive and collaborative work environment.

• Safety & Compliance:

  • Adhere to all safety protocols and company policies, especially when handling hazardous or sensitive chemicals.

  • Maintain a clean and organized work area and ensure proper maintenance and calibration of laboratory equipment.

  • Stay updated on the latest regulatory guidelines and industry trends.