Chemist - Analytical R&D
Edison-New Brunswick Metro Area, NJ
BS, MS or PhD in Chemistry
2 - 8 years of experience
Responsible for method development/validation experiment/reports, performing laboratory research and development under minimal guidance.
Responsibilities will include, but are not limited to, the following:
Generate protocols, data and reports for the preparation of method development, validation and transfer reports.
Support drug substance and drug product impurity characterization and identification.
Support drug substance process development including characterization of starting materials, intermediates and final API.
Support drug product formulation and process development including characterization of the process and finished product.
Performs troubleshooting within method guidance.
Other duties as assigned by the supervisor.
Experience in late-stage analytical development of DS and DP.
Experience in generating method development/validation report, stability data report for inclusion in regulatory filings
Working knowledge of Empower required.
Extensive laboratory experience with and in-depth knowledge of conventional laboratory characterization techniques such as HPLC, GC, UV, dissolution and mass spectrometry is a must.
Fluency in synthetic chemistry, drug substance processing, formulation development, pharmaceutical processing or pharmaceutical sciences is expected.
Strong problem-solving and troubleshooting skills.
Strong capabilities in experimental design and execution.
Ability to work independently
In-depth knowledge of cGLP/GMP; applicable FDA and ICH guidances a must
Knowledge of dissolution methods developing and testing
Familiar with USP and other compendia