Are you a seasoned analytical professional who is looking to play an intricate role in advancing your company's projects and scope? Are you skilled in method development and working with APIs? If so, please apply!
This position is primarily responsible for the laboratory testing of raw materials, packaging materials, in-process, release and stability samples for developmental and pre-commercial drug products.
Responsibilities:
- Conduct advanced analytical research and develop analytical methods to test pharmaceutical products for conformance to established specifications
- Conduct literature searches and be the custodian of the assigned projects
- Perform testing to qualify raw materials vendors and assist in establishing product specifications
- Gather, compile and compose documents needed for regulatory IND/NDA/ANDA submissions
- Prepare/review modules for ANDA/NDA submission
- Develop and validate analytical test methods for assay, dissolution, preservatives in drug products
- Develop and validate test methods for residual solvents and impurities/degradation products in drug substances/excipients/drug products
- Develop and validate analytical cleaning validation methods and perform testing of cleaning validation samples and generate analytical report
- Perform trouble-shooting and investigations under the direction of management
Qualifications/Education:
- BS Degree in Chemistry or related field
- 8 years of pharmaceutical experience
