About this role
Key Responsibilities
A. Analytical Method Development & Optimization
Develop, optimize, and establish analytical methods for pharmaceutical formulations and development samples.
Perform analytical testing using techniques such as HPLC, UV-Visible Spectrophotometry, Dissolution, and other relevant instruments.
Troubleshoot analytical challenges and optimize methods to achieve accurate, precise, and reproducible results.
Support the development of stability-indicating analytical methods.
B. Analytical Method Validation & Verification
Execute analytical method validation, verification, and transfer activities as per approved protocols.
Evaluate analytical parameters such as specificity, linearity, accuracy, precision, robustness, and solution stability.
Prepare and review analytical protocols, reports, and supporting documentation.
C. Formulation Development Support
Provide analytical support to formulation development projects, including R&D trials, optimization batches, and characterization studies.
Coordinate with Formulation Development Scientists to understand product requirements and analytical challenges.
Ensure timely completion of analytical activities in line with project timelines.
D. Instrument Handling & Laboratory Operations
Operate, maintain, and troubleshoot analytical instruments and laboratory equipment.
Ensure proper instrument utilization, calibration, and qualification in coordination with relevant departments.
Maintain laboratory housekeeping, safety, and compliance with standard operating procedures.
E. Data Integrity & Documentation
Generate, review, and maintain accurate analytical data and laboratory records.
Ensure compliance with Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and applicable regulatory guidelines.
Prepare analytical reports, specifications, test methods, and other technical documents.
Ensure data integrity and traceability of all analytical activities.
F. Investigation & Problem Solving
Support Out-of-Specification (OOS), Out-of-Trend (OOT), and analytical deviation investigations.
Identify root causes of analytical failures and recommend corrective and preventive actions.
Participate in continuous improvement initiatives for analytical methods and laboratory processes.
G. Cross-Functional Collaboration
Collaborate with Formulation Development, Quality Assurance, Quality Control, Regulatory Affairs, and other R&D functions.
Provide analytical inputs during project reviews and technical discussions.
Support regulatory submissions by providing analytical data and technical documentation when required.
H. Team Development & Knowledge Sharing
Guide and support Research Associates and junior team members in analytical activities.
Share technical knowledge and best practices related to analytical techniques.
Participate in technical training and capability-building initiatives.
4. Key Deliverables
Timely completion of analytical method development and optimization activities.
Reliable and reproducible analytical results.
Successful execution of validation and verification protocols.
Accurate and compliant analytical documentation.
Effective resolution of analytical challenges.
Analytical support for formulation development projects within agreed timelines.