Senior Scientist, Science & Technology
On-siteShawnee, Kansas, United States
Job Summary
Lead preparation of protocols and execution of cGMP analytical method development, transfer, verification, and validation for active ingredients, raw materials, cleaning verification, and finished drug product analysis. Independently manage design and execution of method transfer, verification, and validation protocols, while overseeing multiple concurrent analytical projects. Serve as a mentor to other analytical development positions, guiding equipment utilization, SOP application, and good lab documentation. Setup and qualify new laboratory instrumentation, and perform detailed records for method development, optimization, and routine analysis following approved methodologies and FDA regulations. Design and execute cleaning validation protocols to assist in report writing.
Required Qualifications
- Bachelor's degree in chemistry or related Science field
- Work experience in cGMP and/or GLP chemistry lab environment
- Minimum of 8+ years of work experience with B.S.
- Minimum of 6+ years of work experience with M.S.
- Proficiency at HPLC/GC analysis and preparation of reagents and sample solutions for testing
- Proficiency with wet chemistry testing methodologies and techniques such as pH, viscosity, density, particle size testing, titration
- Knowledge of GMP and FDA manufacturing regulations
- Ability to analyze and interpret data
- Strong written and oral communication skills
Desired Qualifications
- Experience with mass spec methods and instrumentation
- Demonstrated ability to operate laboratory analytical instrumentation and be able to assist in the troubleshooting and calibration of laboratory equipment
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