Key Responsibilities
1. Method Development & Optimization
• Design and develop stability-indicating analytical methods for current chemical entities (NCEs), advanced intermediates.
• Optimize existing methods to improve sensitivity, reduce runtime, and increase robustness for commercial plant trials.
• Perform forced degradation studies (acid, base, peroxide, thermal, and photolytic) to establish structural stability-indicating profiles.
• Develop customized testing protocols for reaction monitoring (in-process checks) to support Process R&D; scale-up activities. 2. Method Verification/Validation & Technical Transfer
• Draft detailed, audit-ready Method Validation Protocols and Reports in strict accordance with reference standards.
• Execute validation parameters including specificity, linearity, accuracy, precision, LOD/LOQ, and robustness.
• Lead the Analytical Method Transfer (AMT) process to commercial Quality Control plants, providing hands-on troubleshooting and technical training to QC analysts during site absorption. 3. Advanced Instrumentation & Troubleshooting
• Routine operation, calibration, and structural troubleshooting of advanced analytical hardware:
• Chromatography: High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), Gas Chromatography (GC) with headspace auto-samplers.
• Spectroscopy & Wet Chemistry: UV-Vis, FT-IR, Karl Fischer (KF) titrators, and auto-titrators.
• Interpret complex analytical data including impurity profiling, residual solvent analysis via GC-Headspace, and structural characterization.
• Act as the primary technical point of contact to resolve baseline anomalies, system suitability failures, or instrument errors. 4. QMS, Compliance & Documentation
• Maintain accurate,



contemporaneous, and audit-ready data documentation in compliance with standards.
• Author critical quality documents: Standard Operating Procedures (SOPs), Standard Test Procedures (STPs), and Specifications.
• Participate in data integrity compliance, supporting Quality Assurance (QA) in investigating Out of Specification (OOS), Out of Trend (OOT), and deviations within the R&D; space. Core Competencies & Technical Skills
• Method Development Mastery: Proven capability in creating reverse-phase HPLC/UPLC methods, chiral separations, and volatile organic impurity methods via GC.
• Regulatory Frameworks: Thorough understanding of regulatory frameworks including ICH, USFDA, EMA, and local regulatory bodies.
• Impurity Profiling: Experience evaluating trace impurities, degradation products, and genotoxic impurities in API intermediates.
• Data Integrity: Complete familiarity with FDA’s ALCOA+ data integrity principles and processing software (e.g., Empower, Chromeleon, LabSolutions). Educational Qualification & Experience
•

Education:
• M.
Sc. in Analytical Chemistry / Organic Chemistry / Industrial Chemistry, or
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Experience:
2 to 5 years of core experience in an Analytical R&D; / ADL facility focused on API-intermediates or specialty chemical synthesis lines. Key Performance Indicators (KPIs)
• Timeline Adherence: Successful development and validation of methods within targeted project milestones to facilitate timely pilot plant trials.
• First-Time-Right Transfer: Minimizing method rejections or system suitability failures during AMT to commercial QC labs.
• Audit Readiness: Maintaining 100% compliant laboratory documentation with zero critical observations during external customer or regulatory audits.

📌 Analytical Development Executive (Mumbai)
🏢 Anshul Specialty Molecules Private
📍 Mumbai