Job Overview:
Scientific Writer with robust 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

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