Team Lead - AR&D

Key Requirements:

• Conducting in-depth Literature and making analytical methods development plan for Solid orals, Liquid orals and parental formulations
• Develop new method development concepts for Assay, RS and Dissolution, assists in the development of project plans and feasibility assessments.
• Develop experimental programs, work plan and prioritize assignments to meet project objectives within defined timelines
• Review and analysis of experimental data and design of further method optimization studies
• Conducting and monitoring of Pre -formulation studies, Solubility studies, forced degradation studies and Reverse engineering studies, Reference product characterization
• Maintain analytical instruments such as HPLC, UV, IR, Dissolution, GC, etc.
• Monitoring of stability studies and Data interpretation
• Identify and manage the potential risks within projects in a timely fashion
• Arrange and management inventories (Solvents, Columns, RS/WS, RLD etc.) required for projects.
• Conducting root cause analysis and trouble shooting
• Co-ordinate with cross functional teams for smooth flow of projects
• Review of technical documents like STP, Draft specifications, AMV protocol/report and DDR etc.
• Monitoring and providing technical support for Analytical method transfer activities.

Desired qualifications: M.Pharmacy/ MSc analytical chemistry

Desired skills:

• Proactive self-starter who is comfortable working independently in a fast-paced environment while maintaining attention to detail
• Strong conceptual, analytical method development and validation skills
• Adequate Job knowledge and exposure to QbD, DoE and statistical interpretation etc.
• Knowledge on Regulatory guidelines for USA/Europe/ROW markets
• Trouble shooting and Root cause analysis skills