Job Title: Scientist-II – Analytical R&D
Reports to: Manager, Analytical R&D
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.
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 Senior Scientist,
Performs experiments and studies such as unknown impurity
identification, reverse engineering, compatibility studies,
degradation studies independently or under the supervision of a
Assist in writing protocols, reports and technical documents
including but not limited to development, validation and study.
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.
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