Subrat Biswas
Results-driven pharmaceutical scientist with 4.7+ years specializing in API Process Development, non-infringing route development, scale-up, and technology transfer. Experienced in complex molecule synthesis including oncology and high-potency APIs.
Technical Expertise
I work at the intersection of chemistry and pharmaceutical development — designing scalable, compliant, and cost-effective synthetic routes for Active Pharmaceutical Ingredients from early feasibility to commercial manufacturing.
My work spans impurity profiling, QbD-driven process optimization, and regulatory documentation for global markets including USFDA, EMA, and ANVISA.
I hold an M.Sc. in Organic & Medicinal Chemistry and complement my bench science with skills in Python, MS Project, and AI/ML fundamentals for business applications.
Professional Journey
- Patent & journal review for non-infringing route development and IP risk mitigation
- Feasibility studies, process development, and optimization — improved yield up to 80%
- Lab-scale validation batches ensuring scalability, reproducibility, and robustness
- Structural elucidation using NMR, FTIR, and MS; solid-state analysis via XRD, TGA, DSC
- Impurity profiling — nitrosamines, genotoxic (ICH M7), and elemental impurities (Q3D)
- Synthesis and characterization of process-related impurities and intermediate standards
- QbD studies to define CPPs and CQAs; carryover studies for cross-contamination risk
- Authored DMF, PrePIF, QbD reports, and process packages for regulatory submissions
- Scaled up APIs from lab (0.5g–100g) to pilot (500g–5kg) to commercial (up to 100kg)
- Synthesized API intermediates and performed route scouting
- Conducted impurity synthesis and analytical characterization
- Executed purification via crystallization, distillation, and chromatography
- Scaled 5 API intermediates from mg scale to 200 kg, achieving >99.0% purity by HPLC
- Solved advanced chemistry problems including complex reaction mechanisms
- Delivered structured explanations and reviewed academic content for quality
Key Molecules Developed
Global Market Exposure
Academic Background
Get in Touch
I'm open to collaborations, research opportunities, and discussions on API development, process chemistry, and pharmaceutical sciences.
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