Assistant Manager (FR&D)

Position: Assistant Manager - F&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, if need to visit CMO.

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