The Analytical Method development & Validation Section Head will oversee all activities related to analytical method development, optimization, and validation. This role involves strategic leadership, ensuring compliance with EDA as well as global standards (ICH, FDA, EMA), and providing technical guidance on analytical methods for pharmaceutical products. The successful candidate will be responsible for managing a team of scientists and analysts, driving projects to meet quality, timelines, and regulatory expectations.

Key Responsibilities:

• Lead and oversee the development, validation, and transfer of analytical methods.

•  Ensure all methods are compliant with regulatory requirements and align with EDA, ICH, FDA, and EMA guidelines.

• Develop and implement strategies for method optimization, troubleshooting, and validation processes.

• Develop and issue analytical methods, establish method specifications and define acceptance criteria within the necessary thresholds, ensuring compliance with regulatory standards set by ICH, WHO, FDA and EMA.

•  Manage a team of analytical chemists, providing mentorship, training, and performance feedback.

•  Coordinate with cross-functional teams (Quality, R&D, Production) to support product development and regulatory submissions.

• Monitor and evaluate emerging trends in analytical science and adapt methods accordingly.

• Lead investigations related to method-related OOS/OOT results, deviations, and CAPA implementation