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