utilize innovative analytical characterization technologies to drive late-stage pharmaceutical drug product development and commercialization
analytical method development and validation
drug product testing and analytical investigations in a cGMP environment
drug product and manufacturing process characterization
drug product stability studies
specification development
manufacturing process scale-up and validation support
preparation of Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions
responses to regulatory questions
collaborate in a dynamic, integrated, and multidisciplinary team environment
Requirements
PhD in Analytical Chemistry or related discipline with 4+ years of relevant pharmaceutical development experience or MS in Analytical Chemistry or related discipline with 10+ years of relevant pharmaceutical development experience
Strong background and extensive hands-on experience with common analytical techniques such as Ultrahigh/High Performance Liquid Chromatography (UHPLC/HPLC), Ultraviolet (UV) and Infrared (IR) spectroscopy, Karl Fischer titration, and dissolution
Strong chemistry knowledge
Demonstrated problem solving ability
Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills
Ability to work in a team environment with cross-functional interactions
Benefits
medical, dental, vision healthcare and other insurance benefits (for employee and family)
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