Manager – Pharma Method Validation Lab

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Role Summary

The Manager – Pharma Method Validation will lead all analytical method validation activities for pharmaceutical drug substances, drug products and related matrices. The person will be responsible for planning, executing and reviewing validation studies as per global regulatory guidelines, ensuring compliance with ISO/IEC 17025, ICH, USFDA, MHRA and other applicable requirements. This role requires strong technical command over chromatographic and mass spectrometric techniques along with capability to lead a validation team.

Key Responsibilities

1. Method Development, Validation & Verification

• Lead end-to-end method development and validation for assay, content uniformity, dissolution, impurities, RS, degradation products etc.
• Execute validation as per ICH Q2(R2) / Q14 principles and prepare complete documentation.
• Perform verification and transfer of pharmacopoeial methods (USP, BP, IP, EP).
• Conduct robustness, ruggedness, specificity, precision, accuracy, linearity, LOD/LOQ, solution stability and system suitability evaluations.

2. E&L (Extractables & Leachables) & Packaging Studies

• Lead Extractables and Leachables studies for container–closure systems.
• Plan worst-case evaluations, material compatibility studies and risk assessments.
• Perform E&L profiling using GC-MS/MS, LC-MS/MS and HRMS platforms.
• Prepare E&L reports as per PQRI, USP <1663>/<1664> and global regulatory expectations.

3. Stability Studies & Degradation Profiling

• Support forced degradation studies for stability-indicating method validation.
• Ensure alignment with ICH Q1 guidelines for stability programs.
• Review chromatographic degradant profiling and mass-based identification when required.

4. Regulatory & Guideline Compliance

Strong working knowledge of the following:

• ICH Q1, Q2(R2), Q3, Q6A, Q14
• USP/EP/BP/IP monographs
• USFDA, MHRA, WHO TRS and current industry practices
• Data integrity (ALCOA+) & GMP expectations
• ISO/IEC 17025 compliance for documentation, records and technical operations.

5. Data Review, Documentation & Reporting

• Review chromatograms, integration, calculations, raw data and validation summary reports.
• Ensure all validation files, protocols, reports and logbooks meet QMS requirements.
• Respond to regulatory, QA and client inquiries with technical clarity.

6. Team Management & Coordination

• Lead a team of validation chemists and analysts.
• Train staff on validation design, regulatory expectations and instrument troubleshooting.
• Coordinate with QA, stability, packaging and instrumentation teams.

Qualifications

• M. Pharm / M.Sc in Analytical Chemistry, Chemistry or related field.
• Minimum 10–15+ years in pharma analytical method validation.
• Strong experience on HPLC, UHPLC, LC-MS/MS and GC-MS/MS.
• Experience in E&L studies preferred.

Key Attributes

• Strong communication and spoken English.
• Sharp analytical judgement and attention to detail.
• Ability to lead under regulatory pressure.