Formulation And Development Manager

Role & responsibilities

Literature search and review from all the available sources related to product.

Targeting the development of stable, scalable, bio-equivalent and Cost- effective generic formulations

To discuss with the higher designees such as team leader regarding the development strategy and plan.

Ensure product formulations comply with product label claims and established specification. Finding Ways to enhance solubility of newly found drugs

Preparing Thermo cycling study protocol, thermal excursion study protocol and photostability protocol for prepared batches.

Ensure Product formulations are as per FDA guidance and regulations.

Conducted bench trials, Pilot trials and stability studies for new product development and reformulation.

Formulation Development involving in various steps like Literature Search, Reference Product Characterization.

Check Updates, latest information, guidance form Daily Med and Drugs @FDA,Dissolution Database, IIG limits, Monographs, New Approvals and Submissions etc.

Indenting Raw Materials, API, Reference Products, tooling and Coating Materials etc.

Co-ordination with various departments like Analytical, Regulatory Affairs, QA, Technology Transfer, Production.

To maintain lab and instruments/equipment usage records.

Maintained accurate LNB records of all experimental data.

Preparation of various document such as stability protocol, MFC, Stability Compilation data, PDR, Tech Transfer documents.

Preferred candidate profile