Assistant Manager - R&D (API Process Development)

Synnat Pharma; Visakhapatnam; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Synnat Pharma in Visakhapatnam, Andhra Pradesh, seeks a meticulous Asst. Manager R&D to spearhead process development of intermediates and APIs.

You will identify cost-effective, non-infringing synthetic routes and develop robust, safe, sustainable manufacturing processes while interpreting analytical data to confirm structure, purity, and impurity profiles. In this role you will lead development activities, optimize reaction parameters, implement PAT, transfer technology across functions, and

Responsibilities

• Lead process development activities for intermediates and APIs, ensuring scalability and efficiency.
• Design and execute experiments to optimize reaction parameters, yields, and purity profiles.
• Develop robust and cost-effective synthetic routes for target molecules.
• Implement process analytical technology (PAT) to monitor and control critical process parameters.
• Troubleshoot process-related issues and implement corrective actions to improve process performance.
• Collaborate with cross-functional teams, including manufacturing and analytical departments, to ensure seamless technology transfer.
• Present research findings and recommendations to the R&D team.
• Prepare detailed process descriptions and flow diagrams for selected synthetic routes.
• Analyze reaction mechanisms and propose improvements to optimize reaction conditions.
• Design experiments to evaluate the feasibility and efficiency of different synthetic routes.
• Conduct literature searches and patent analysis to identify non-infringing synthetic processes.
• Identify and evaluate potential synthetic routes for target molecules, considering cost, safety, and environmental impact.
• Collaborate with the analytical department to resolve analytical issues and improve analytical methods.
• Ensure compliance with regulatory guidelines and quality standards.
• Prepare analytical reports and documentation to support regulatory filings.
• Conduct impurity profiling studies to identify and characterize impurities in drug substances.
• Develop and validate analytical methods for the analysis of intermediates and APIs.
• Interpret analytical data (HPLC, GC, NMR, LC-MS, IR, XRD etc.) to confirm structure, purity, and impurity profiles.
• Ensure compliance with environmental regulations and safety standards.
• Conduct risk assessments to identify potential hazards and implement safety measures.
• Optimize process conditions to reduce energy consumption and waste generation.
• Evaluate alternative solvents and reagents to improve process safety and sustainability.
• Implement green chemistry principles to minimize waste and environmental impact.
• Identify opportunities to reduce raw material costs and improve process efficiency.
• Participate in internal and external audits.
• Ensure compliance with data integrity principles and quality standards.
• Contribute to the preparation of regulatory filings and patent applications.
• Present research findings and recommendations to the R&D team and management.
• Prepare detailed process development reports and technical documents.
• Maintain accurate and up-to-date laboratory notebooks and electronic records.
• Contribute to a positive and collaborative work environment.
• Stay current with the latest scientific literature and industry trends.
• Maintain effective communication with stakeholders to ensure project alignment.
• Participate in team meetings and contribute to project planning and execution.
• Provide technical guidance and mentorship to junior scientists and research associates.
• Collaborate with cross-functional teams, including manufacturing, analytical, and regulatory departments.

Job description

We seek a meticulous Asst. Manager R&D to spearhead process development of intermediates and Active Pharmaceutical Ingredients (APIs) at Synnat Pharma. As a key member of our Research & Development department, you will be instrumental in identifying cost-effective and non-infringing synthetic processes, developing robust, safe, and environmentally sustainable manufacturing processes, and interpreting complex analytical data to confirm structure, purity, and impurity profiles.

Roles & Responsibilities:

API Process Development and Optimization

1. 1. Lead process development activities for intermediates and APIs, ensuring scalability and efficiency.
2. 2. Design and execute experiments to optimize reaction parameters, yields, and purity profiles.
3. 3. Develop robust and cost-effective synthetic routes for target molecules.
4. 4. Implement process analytical technology (PAT) to monitor and control critical process parameters.
5. 5. Troubleshoot process-related issues and implement corrective actions to improve process performance.
6. 6. Collaborate with cross-functional teams, including manufacturing and analytical departments, to ensure seamless technology transfer.

Synthetic Route Design and Analysis

1. 1. Present research findings and recommendations to the R&D team.
2. 2. Prepare detailed process descriptions and flow diagrams for selected synthetic routes.
3. 3. Analyze reaction mechanisms and propose improvements to optimize reaction conditions.
4. 4. Design experiments to evaluate the feasibility and efficiency of different synthetic routes.
5. 5. Conduct literature searches and patent analysis to identify non-infringing synthetic processes.
6. 6. Identify and evaluate potential synthetic routes for target molecules, considering cost, safety, and environmental impact.

Analytical Data Interpretation and Impurity Profiling

1. 1. Collaborate with the analytical department to resolve analytical issues and improve analytical methods.
2. 2. Ensure compliance with regulatory guidelines and quality standards.
3. 3. Prepare analytical reports and documentation to support regulatory filings.
4. 4. Conduct impurity profiling studies to identify and characterize impurities in drug substances.
5. 5. Develop and validate analytical methods for the analysis of intermediates and APIs.
6. 6. Interpret analytical data (HPLC, GC, NMR, LC-MS, IR, XRD etc.) to confirm structure, purity, and impurity profiles.

Cost-Effective and Sustainable Process Development

1. 1. Ensure compliance with environmental regulations and safety standards.
2. 2. Conduct risk assessments to identify potential hazards and implement safety measures.
3. 3. Optimize process conditions to reduce energy consumption and waste generation.
4. 4. Evaluate alternative solvents and reagents to improve process safety and sustainability.
5. 5. Implement green chemistry principles to minimize waste and environmental impact.
6. 6. Identify opportunities to reduce raw material costs and improve process efficiency.

Documentation and Reporting

1. 1. Participate in internal and external audits.
2. 2. Ensure compliance with data integrity principles and quality standards.
3. 3. Contribute to the preparation of regulatory filings and patent applications.
4. 4. Present research findings and recommendations to the R&D team and management.
5. 5. Prepare detailed process development reports and technical documents.
6. 6. Maintain accurate and up-to-date laboratory notebooks and electronic records.

Collaboration and Mentorship

1. 1. Contribute to a positive and collaborative work environment.
2. 2. Stay current with the latest scientific literature and industry trends.
3. 3. Maintain effective communication with stakeholders to ensure project alignment.
4. 4. Participate in team meetings and contribute to project planning and execution.
5. 5. Provide technical guidance and mentorship to junior scientists and research associates.
6. 6. Collaborate with cross-functional teams, including manufacturing, analytical, and regulatory departments.