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