Senior Analytical Chemist
3 weeks ago
We are seeking a seasoned analytical professional to play a key role in advancing our company's projects and scope. If you have expertise in method development and working with APIs, we encourage you to apply.
This position is primarily responsible for laboratory testing of raw materials, packaging materials, in-process, release, and stability samples for developmental and pre-commercial drug products.
Key Responsibilities:
- Conduct advanced analytical research and develop analytical methods to test pharmaceutical products for conformance to established specifications
- Conduct literature searches and serve as the custodian of 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 and 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 reports
- Perform trouble-shooting and investigations under the direction of management
Qualifications/Education:
- Bachelor's Degree in Chemistry or related field
- 12-15 years of pharmaceutical experience
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