Research Scientist- ADL

Purpose: Analytical method development and validation

Key Requirements:

• Conducting Literature search and preparation of Literature Report
• Development and optimization of analytical methods of drug products based on QbD principles and regulatory requirements
• Execute routine Analytical Research activities of drug products and analysis of Development and stability samples
• Operate and maintain analytical instruments such as HPLC, UV, IR, Dissolution, GC, etc.
• Review and evaluate experiments and analytical data
• Interpret data, record and maintain data as per regulatory requirements
• Trouble shooting related to Testing methods, Stability studies, test results and designing of additional experimentations as necessary
• Conducting Pre-formulation studies, Solubility studies, forced degradation studies and Reverse engineering studies, Reference product characterisation
• Preparation and review of Specifications, Method of analysis procedures and Analytical development reports.
• Preparation and review of analytical protocols and reports (Analytical method validation, Method feasibility, Analytical method transfer, etc.)
• Execution of analytical method validation activities for drug products as per regulatory requirements
• Addressing queries received from regulatory agencies

Desired qualification: B. Pharmacy/M.Pharmacy/MSc analytical chemistry

Desired skills:

• Strong conceptual, analytical method development and validation skills
• Must have ability to work on multiple projects as per timelines
• Adequate Job knowledge and exposure to different Analytical methods and instrumentations
• Adequate Job knowledge and exposure to QbD, DoE and statistical interpretation etc.
• Effective collaborative and teamworking skills