Manager (API ADL)

RPG Life Sciences; Kamareddy; On-site; INR 1,200,000 - 2,100,000; Full time

Benefits offered by this job

Job summary

RPG Life Sciences is seeking an experienced scientist to drive Analytical Method Development and related activities. You will develop, optimize, and validate methods for APIs and finished products, transfer methods to QC labs, prepare regulatory documentation, and ensure GMP/GLP compliance.

You will lead analytical projects from development to commercial launch, manage laboratory resources and instruments, mentor the team, and drive continuous improvement across QA and Regulatory affairs.

Qualifications

• Experience in developing and validating analytical methods per regulatory guidelines.
• Experience with stability studies and impurity profiling.
• Strong data integrity and laboratory compliance mindset.
• Familiarity with regulatory documentation and audits.

Responsibilities

• Develop, optimize, and validate analytical methods for APIs and finished products.
• Lead analytical activities for R&D projects from development to launch.
• Coordinate method transfers to QC laboratories and regulatory submissions support.
• Manage ADL resources, instruments, and GMP/GLP compliant operations.
• Mentor scientists; conduct reviews and training.
• Ensure cGMP/ICH/FDA/EMA compliance and audit readiness.

Skills

Analytical method development

Method validation

Regulatory compliance

Project management

Team leadership

Communication skills

Tools

HPLC/UPLC

GC

LC-MS

ICP-MS

UV-Vis/FTIR

Dissolution

Job description

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.