Scientist, Analytical Chemistry
Newark Metro Area, NJ
Responsible for assisting in routine and non-routine sample analysis for drug substance and drug product, generating analytical protocol, data, reports under minimal guidance of a supervisor. Multi-tasking and communicates results according to project timelines.
Responsibilities will include, but are not limited to, the following:
Perform pharmaceutical drug substance and drug product analysis according to existing method, protocol, assist in drug substances and finished products analysis in accordance with cGMP regulations, established protocols, and applicable SOPs.
Adhere to all pertaining compliance requirements.
Contribute data for preparation of development and commercial activities and reports.
Communicates results according to project timelines and works with colleagues and collaborators to understand project needs.
Performs reference standard qualification/requalification tests.
Performs dissolution, assay, impurity, content uniformity, blend uniformity analysis with established methods, specifications and protocols with limited supervision.
Documents laboratory work that is detailed, timely and in compliance with GLP/GMP requirements.
Generate analytical protocol,
Other duties as assigned by his/her supervisor.
Experienced in HPLC, familiar with GC, FT-IR, KF etc. required.
Knowledge of Dissolution method testing
In-depth knowledge of cGLP/GMP; applicable FDA and ICH guidance a must
Familiar with USP and other compendia
Working knowledge of Empower required.
Must have working familiarity with cGMP practice and safety awareness for analytical laboratories.
Strong communication skills and team work spirit
Bachelor, Master, or Ph.D. in Chemistry related discipline, preferably Analytical Chemistry