Job Overview:

Scientific Writer with solid expertise in material science, analytical chemistry, and chemical principles (organic and inorganic) as applied to pharmaceutical formulation, manufacturing, and product lifecycle management.

This role serves as a scientific authority for translating material, analytical, and process knowledge into robust, lifecycle ready CMC documentation. The position is a key enabler of knowledge capture, scientific consistency, and regulatory defensibility across technology transfer, PPQ, and commercial manufacturing.

You work at the interface of science, manufacturing, quality, and regulatory, ensuring that how we understand materials and processes is clearly articulated, justified, and sustained throughout the product lifecycle

Summary of Responsibilities:

These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties as individual contributor globally.

Scientific Leadership CMC Knowledge Translation




- Act as a scientific owner for the development of high quality CMC documentation related to:
- Pharmaceutical raw materials and excipients
- Process aids and contact materials (incl. leachables extractables)
- Material changes, supplier changes, and lifecycle optimization activities
- Translate complex analytical, chemical, and manufacturing data into:
- Scientifically rigorous justifications
- Risk assessments and material qualification reports
- CMC sections supporting variations, supplements, and regulatory responses
- Ensure scientific content is aligned with Quality by Design principles and clearly supports:
- Control strategies
- Defined design space and material attribute justifications
- Lifecycle change management

Analytical Chemistry Chemical Understanding
- Integrate and critically interpret analytical chemistry data, including:
- Physicochemical characterization
- Impurity and degradation profiles
- Elemental and inorgan

📌 Regulatory Operations Expert (Mumbai)
🏢 Fortrea Development India
📍 Mumbai