Team Lead - FR&D

Key Requirements:

• Conducting in-depth Literature and patent search and making formulation development plan for Solid oral and Liquid oral formulations
• Develop new formulation concepts, assists in the development of project plans, business analysis 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 experiments.
• Monitoring of stability studies and Data interpretation
• Formula and process optimization studies - Discussion/design, review and monitoring of PET trials, pH Establishment Trials and PDR Trials
• Identify and manage the potential risks within projects in a timely fashion
• Arrange and management inventories (RM, PM, 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 QnQ, Draft specifications, PDR report and finalization, MFR, PVP, HTSP etc.
• Monitoring and providing technical support for scale up and validation batches

Desired qualifications: M. Pharma

Desired skills:

• Proactive self-starter who is comfortable working independently in a fast-paced environment while maintaining attention to detail
• Hands on experience in formulation development of solid orals and liquid orals for regulated markets
• Knowledge on QbD and DoE concepts
• Knowledge on Regulatory guidelines for USA/Europe/ROW markets
• Trouble shooting and Root cause analysis skills