We are searching for an Analytical R&D Scientist to work as a FTE at a specialty pharmaceutical company developing generic and branded pharmaceutical products. The primary focus will be on the development of oral solids, liquids and semi solids for FDA applications.
Responsibilities:
- Developing and validating HPLC/GC and other analytical test methods, and optimizing existing test method.
- Performs analytical testing on Research & Development 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.
- 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
Must Haves:
- Bachelors degree
- 3+ years of experience with analytical testing in R&D