R&D Assistant Manager

Key Responsibilities1. Process Development & Optimization

• Develop new synthetic routes for APIs and intermediates.
• Optimize existing processes for better yield, purity, cycle time, and cost efficiency.
• Conduct lab experiments, reaction monitoring, and troubleshooting.
• Ensure scalability of processes from lab to pilot to plant.

2. Technology Transfer

• Prepare and review technology transfer documents, including PDRs (Process Development Reports) and TTDs (Technology Transfer Documents).
• Support smooth transfer of processes from R&D to pilot / production.
• Work closely with production, QC, and QA teams during scale-up.

3. Regulatory & Documentation

• Prepare and review laboratory records, development reports, and data summaries.
• Ensure compliance with GLP, GMP, ICH, and regulatory standards.
• Provide technical support for DMF/CTD filings and customer documentation.
• Support impurity profiling, analytical method development (in coordination with AR&D).

4. Analytical & Characterization Support

• Collaborate with Analytical R&D (AR&D) for method development, validation, and characterization.
• Ensure proper analysis of intermediates and final API using NMR, LCMS, HPLC, GC, FTIR, etc.
• Troubleshoot analytical issues during development and scale-up.

5. Innovation & Intellectual Property

• Support patent landscaping, literature survey, and identification of non-infringing processes.
• Contribute to filing of process patents and protecting company IP.

6. People & Project Management

• Guide and supervise R&D chemists and officers in lab activities.
• Allocate resources, monitor project timelines, and report progress to management.
• Train team members on safe laboratory practices and regulatory expectations.

7. Safety & EHS

• Ensure safe handling of hazardous chemicals and reactions (HCl, NaH, cyanides, high-pressure reactions, etc.).
• Adhere to all EHS guidelines in laboratory and pilot areas.

Key Skills & Competencies

• Strong expertise in organic synthesis, route scouting, process development, and scale-up.
• Hands-on knowledge of analytical techniques (HPLC, GC, NMR, LCMS, DSC, KF).
• Knowledge of regulatory guidelines (ICH Q7, USFDA, EMA, CDSCO).
• Experience in impurity profiling, process safety, and DoE (Design of Experiments).
• Project management, leadership, and cross-functional collaboration.
• Good communication and documentation skills.

Job Type: Full-time

Pay: ₹40,000.00 - ₹60,000.00 per month

Benefits:

• Health insurance
• Leave encashment
• Provident Fund

Work Location: In person