Job Description:

Key Responsibilities

- Process Development:

- Design and execute multi-step organic synthesis experiments to develop recent 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.

📌 Chemist / Officer - Research & Development (Vadodara)
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📍 Vadodara