- Support raw material qualifications, method transfers, and validation of assays such as UV-VIS Spectrometry, SDS Page, wet chemical analysis, utility testing (e.g. TOC, conductivity, and gas testing) and more complex assays including GC solvent analysis and various HPLC methodologies (e.g. peptide map and carbohydrate analysis).
- Review compendial methods (USP, EP, JP) for alignment with internal raw material test procedures and specifications.
- Perform routine/non-routine data analysis calculations.
- Document analytical data under cGMP and corporate guidelines.
- Participate and resolve laboratory investigations of unexpected analytical results.
- Write/review SOPs, test methods, material specifications, validation protocols and reports.
- Support cGMP laboratory initiatives following laboratory SOPs.
- Other duties may be assigned.
Bachelor’s degree in chemistry, biochemistry, or related scientific discipline required.
Master’s degree preferred.
6 years experience with a Bachelors or 4 years with a Masters
Interested candidates may contact at Praveen.arora at artechinfo.com or 973-507-7593