Job Overview
Execute analytical methods and provide general analytical support, such as release and stability testing of drug substances and drug products. Able to organize routine work independently and evaluate, troubleshoot and interpret generated data. Demonstrated understanding of method development and qualification/validation principles.
Routinely and effectively interacts with clients to discuss data and methods.
Works on problems of moderate and sometimes advanced scope where analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action.
Responsibilities
- Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines
- Independently develop and evaluate methodologies, design and implement experiments
- Participate in experimental design, including development of methods and testing requirements to demonstrate method suitability
- Maintain compliant records with little or no supervision
- Able to write technical documents with assistance
- Strong understanding and proficiency in use and maintenance of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks
- Perform assigned tasks carefully, safely and on schedule according to SOPs and supervisor instructions
- Set up various instrumentation for testing according to written test methods and with little to no supervision
- As needed, troubleshoot laboratory instrumentation