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
- 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