Scientist - R&D

Job Description

Job Description

The Analytical R&D Scientist II is responsible to develop and establish new analytical methods using advanced analytical techniques that meet the expected FDA standard, independently or under the supervision of a Senior Scientist. The primary focus will be on the development of oral solids, liquids and semi solids for FDA applications. Analytical R&D Scientist II should be able to work on the bench, manage projects while working with other scientists and collaborating with other departments.

Responsibilities :

• Analytical R&D Scientist-II will be responsible for developing and / or validating HPLC / GC and other analytical test methods, and optimizing existing test method independently or under the supervision of a Manager,
• Performs analytical testing on R&D batches and associated stability studies and generate stability analysis report.
• Analytical testing will include Assay, preservative content, LOD, water content, identification test, dissolution, disintegration, residual solvents, related substances etc.
• Provide mentorship, training, and guidance to associate level staff and contribute to their development.
• Performs experiments and studies such as reverse engineering, compatibility studies, degradation studies independently or under the supervision of a Senior Scientist. Assist in writing protocols, reports, and technical documents including but not limited to development, validation, and study.
• Ensure compliance with DEA and site requirements regarding the handling, use and disposal of controlled substances.
• Ensure compliance with company policies and SOPs as well as FDA and other applicable guidelines

Education, Skills, and Experience :

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