We are looking for a dynamic and experienced Senior Research Associate (SRA) to join our API Research & Development / Synthetic Chemistry team at Walter Bushnell Research Center, Gurugram.

In this role, you will be responsible for designing, executing, and scaling synthetic routes for Active Pharmaceutical Ingredients (APIs), conducting process optimization, handling impurity synthesis and nitrosamine risk assessments, and compiling complete technical documentation for technology transfer.

Key Responsibilities

- Synthetic Chemistry & Process Development:
- Design, optimize, and validate multi-step organic synthesis routes for APIs, custom molecules, and specialty chemicals (mg to kg scale).
- Conduct route scouting, literature searches, retrosynthetic analysis, and feasibility/stretchability trials.
- Identify Critical Process Parameters (CPPs), optimize processes for yield, quality, cost-effectiveness, and process safety.
- Impurity Synthesis & Nitrosamine Assessment:
- Synthesize, isolate, profile, and characterize process-related impurities, degradation products, Potential Genotoxic Impurities (PGIs), NDSRIs, and nitrosamines.
- Perform Nitrosamine Risk Assessments based on API structure, synthetic routes, and excipients; conduct susceptibility trials under nitrosation conditions.
- Technical Documentation & Protocols:
- Draft and compile Process Development Reports (PDR) and Technology Transfer Dossiers (TTD).




- Prepare and update Standard Operating Procedures (SOPs) and process validation protocols.
- Scale-Up & Technology Transfer:
- Develop scalable synthetic processes suitable for pilot plant and commercial manufacturing.
- Support lab validation batches and partner with scale-up and plant teams for seamless technology transfer using TTD packages.
- Maintain GLP/cGMP compliance, ensure lab safety, and mentor laboratory assistants in handling hazardous chemicals.

Desired Candidate Profile

- Education:
- M.Sc. in Organic Chemistry / Synthetic Chemistry with 5 to 8 years of API R&D; experience.
- OR
- Ph.D. in Synthetic Organic Chemistry with 2 to 4 years of industrial process chemistry experience.
- Key Skills & Competencies:
- Solid expertise in organic reaction mechanisms, multi-step synthesis, purification, crystallization, and scale-up.
- Hands-on experience with analytical data interpretation: NMR ($^1text{H}$, $^{13}text{C}$), HPLC, GC, LC-MS, XRD, FTIR, TLC.
- Proven track record in compiling PDR, TTD, SOPs, and using DoE (Design of Experiments) software.
- Working knowledge of ICH guidelines, cGMP/GLP standards, and nitrosamine risk assessment methodologies.
- Proficiency in Excel for cost/COGS calculations and preparing PowerPoint presentations.

Intrested Candidate can directly share CV at [email protected]

📌 Senior Research Associate - API R&D (Synthetic Chemistry) (Gurugram)
🏢 Walter Bushnell
📍 Gurugram