Job Description:

Key Responsibilities

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Process Development:

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

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

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

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Technology Transfer:

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

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

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

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Analytical and Data Management:

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

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Ensure all experimental data and observations are meticulously recorded in a laboratory notebook,



maintaining Good Laboratory Practices (GLP).

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

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Impurity Profiling:

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

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

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Collaboration & Communication:

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

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

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

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Safety & Compliance:

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

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Maintain a clean

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