Assistant Manager - FR&D

Position:

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:

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