Job Description:

Key Responsibilities
Process Development:
Design and execute multi-step organic synthesis experiments to develop current 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 Positive 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 workplace.
Safety & Compliance:
Adhere to all safety protocols and company policies, especially when handling hazardous or sensitive chemicals.
Maintain a clean

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