Research Scientist - ADL

Role & responsibilities

Analytical Method Development & Validation

• Develop, optimize, and validate analytical methods for APIs, intermediates, raw materials, and in-process samples.
• Perform analytical method development and validation using HPLC, UPLC, GC, LC-MS/MS, UV and related analytical techniques.
• Execute assay, related substances, and residual solvent method validations as per ICH guidelines.
• Prepare validation protocols, reports, and regulatory documentation.
• Support analytical troubleshooting, method transfer, and technology transfer activities.

Impurity Profiling & Characterization

• Conduct forced degradation studies and evaluate degradation pathways.
• Perform impurity profiling, identification, and characterization of unknown impurities.
• Investigate degradation products generated during synthesis, stability, and stress studies.
• Utilize LC-MS/MS and advanced analytical techniques for impurity characterization and root cause investigations.
• Support impurity assessments for regulatory submissions.

Structure Elucidation & Spectroscopic Analysis

• Interpret and elucidate chemical structures using NMR, Mass Spectrometry, FTIR, and UV spectroscopy.

• Analyze and interpret:

• 1H NMR

• 13C NMR

• DEPT

• COSY

• HSQC

• HMBC

• NOESY

• Perform structural confirmation of APIs, intermediates, impurities, and reference standards.

• Prepare characterization reports and scientific documentation.

Instrument Management

• Operate, troubleshoot, maintain, and calibrate analytical instruments including:

• HPLC / UPLC

• GC

• LC-MS/MS

• NMR

• FTIR

• UV-Visible Spectrophotometers

• Ensure compliance with calibration schedules, SOPs, data integrity, and laboratory best practices.

Team Leadership & Project Management

• Lead, mentor, and develop a team of analytical scientists.
• Plan and monitor analytical projects and resource allocation.
• Review analytical data, laboratory records, protocols, and reports.
• Provide technical guidance and scientific leadership to project teams.
• Collaborate with R&D, QA, Regulatory Affairs, Manufacturing, and Procurement teams.

Regulatory & Vendor Coordination

• Coordinate with vendors for impurity standards, solvents, reference standards, and raw materials.
• Support qualification and characterization of analytical reference standards.
• Prepare technical justifications and regulatory documentation.
• Participate in customer audits, regulatory inspections, and quality audits.

Reporting & Communication

• Prepare and present project updates, technical reviews, and management reports.
• Track project milestones, risks, action plans, and deliverables.
• Communicate analytical findings effectively to internal and external stakeholders.

Compliance & Documentation

• Maintain laboratory notebooks, analytical records, and electronic documentation.
• Ensure compliance with GMP, GLP, Data Integrity, and internal SOP requirements.
• Support deviation investigations, OOS/OOT investigations, CAPA implementation, and change control activities.
• Ensure audit readiness and regulatory compliance.