Position: Research Fellow -CMC (Analytical)
Location: Hyderabad
Duration: 12 months
Reports to: Associate Director - CMC (Analytical)
Department: CMC (Analytical)
Role Overview:
The Analytical Research & Development Intern will assist in the development, validation, and optimization of analytical methods used for the analysis of pharmaceutical products, raw materials, and intermediates. The intern will gain hands-on experience with modern analytical techniques, data interpretation, and reporting, contributing to the success of drug development projects.
Key Responsibilities:
Method Development & Validation:
Assist in developing and validating analytical methods such as HPLC, GC, FTIR, NMR, UV-Vis, and dissolution testing.
Support the optimization of analytical procedures to ensure precision, accuracy, and robustness.
Sample Preparation & Analysis:
Conduct sample preparation, including dissolution, dilution, extraction, and filtration for testing.
Perform routine and non-routine analyses of pharmaceutical samples, including APIs, excipients, and finished dosage forms.
Ensure the accuracy of data collection, processing, and reporting.
Documentation & Compliance:
Document experimental procedures, observations, and results according to Good Laboratory Practices (GLP).
Maintain detailed records in laboratory notebooks and prepare reports for review by senior scientists.
Follow company protocols and regulatory guidelines (FDA, ICH, USP, etc.) to ensure compliance.
Data Interpretation & Reporting:
Assist in interpreting analytical data and troubleshooting analytical methods.
Present findings and provide recommendations during team meetings.
Prepare technical reports, Standard Operating Procedures (SOPs), and analytical test methods.
Lab Maintenance & Safety:
Ensure proper use, maintenance, and calibration of laboratory equipment.
Adhere to all safety protocols, including the handling and disposal of chemicals and hazardous materials.
Maintain a clean and organized laboratory environment.
Cross-Functional Collaboration:
Work closely with other departments, such as formulation development, regulatory affairs, and quality assurance, to support drug development programs.
Participate in project discussions and contribute to problem-solving initiatives.
Qualifications:
Completed/ awaiting final result - master’s in chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related field from a reputed university.
Knowledge of analytical techniques such as HPLC, GC, and spectroscopy is preferred.
Familiarity with regulatory guidelines (FDA, ICH) is a plus.
Strong analytical, problem-solving, and organizational skills.
Ability to work independently and in a team environment.
Proficient in MS Office Suite (Word, Excel, PowerPoint).
Excellent verbal and written communication skills.
Opportunities & Learning Outcomes:
Gain practical, hands-on experience in a pharmaceutical R&D environment.
Learn how to develop and validate analytical methods following regulatory guidelines.
Understand the drug development process from an analytical perspective.
Collaborate with multidisciplinary teams and gain exposure to cross-functional areas in drug development.