Analytical Method Development

- Develop, optimize, and validate analytical methods for APIs, intermediates, raw materials, and finished products.

- Perform method validation as per ICH, USP, EP, and regulatory guidelines.

- Provide technical support for analytical troubleshooting and investigations.

Project Management

- Lead analytical activities for R&D; projects from development to commercial launch.

- Ensure timely completion of analytical deliverables.

- Coordinate with Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and Production teams.

Method Transfer & Regulatory Support

- Execute and oversee analytical method transfers to QC laboratories.

- Prepare analytical sections of regulatory submissions (DMF, CTD, ANDA, etc.).

- Support responses to regulatory queries.

Laboratory Management

- Manage ADL resources, instruments, and laboratory operations.

- Ensure calibration, qualification, and maintenance of analytical instruments such as HPLC, GC, UV, FTIR, Dissolution, KF, and LC-MS.

- Monitor laboratory compliance with GMP, GLP, and data integrity requirements.

Team Leadership

- Guide and mentor analytical scientists and executives.





- Conduct performance reviews and training programs.

- Foster a culture of continuous improvement and innovation.

Compliance & Quality

- Ensure compliance with cGMP, ICH, FDA, EMA, and other regulatory requirements.

- Review laboratory documentation, protocols, reports, and SOPs.

- Participate in audits and regulatory inspections.

Technical Skills

- HPLC, UPLC, GC, LC-MS, ICP-MS, UV-Vis, FTIR.

- Method development and validation.

- Stability studies and impurity profiling.

- Data integrity and laboratory compliance.

- Regulatory documentation and audit handling.

Behavioral Competencies

- Leadership and team management.

- Problem-solving and decision-making.

- Project management.

- Cross-functional collaboration.

- Communication and presentation skills.

Key Performance Indicators (KPIs)

- Timely completion of analytical development projects.

- Successful method validations and transfers.

- Regulatory compliance and audit readiness.

- Reduction in analytical investigation timelines.

- Team productivity and development.

📌 Manager (API ADL) (Kamareddy)
🏢 RPG Life Sciences
📍 Kamareddy