As a Scientist within our Materials Characterization department, you will execute analytical methods and provide general analytical support, such as release and stability testing of drug substances and drug products.
Responsibilities
Execute analytical methods and provide general analytical support, such as release and stability testing of drug substances and drug products.
Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines.
Develop and implement test methods utilizing U/HPLC, GC, HPLC/MS, ICP-MS, XRD, LPS and/or various analytical techniques.
Write standard operating procedures (SOPs), method qualification/validation protocols and reports (GMP/GLP), and research study reports.
Follow SOPs and clearly documents all procedures and results in a GMP notebook.
Develop and validate analytical methods for testing of drug substances and drug products.
Perform technical review of notebooks.
Operate HPLC, GC, ICP-MS, XRD, LPS, and other laboratory equipment.
Additionally, you will write standard operating procedures (SOPs), method validation protocols, method validation reports and specifications.
Supply weekly updates on long-term projects.
With guidance, you will prepare well written and organized development reports to convey the quality of the methods to clients.
Qualifications
BS Degree or MS Degree in Chemistry or related discipline plus 1-5 years of industrial experience in a GMP environment is required.
