Key skills
Communication
About this role
Role Overview
- 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
- Responding to regulatory questions
Requirements
- PhD in Analytical Chemistry or related discipline with 3+ years of relevant pharmaceutical development experience or MS in Analytical Chemistry or related discipline with 8+ years of relevant pharmaceutical development experience or BS in Analytical Chemistry or related discipline with 10+ years of relevant pharmaceutical development experience
- Experience with inhalation product development, characterization and testing including aerodynamic particle size distribution (APSD), delivered dose uniformity (DDU), metered dose uniformity (MDU) and particle size distribution (PSD)
- Strong background and extensive hands-on experience with common analytical techniques such as Ultrahigh/High Performance Liquid Chromatography (UHPLC/HPLC), Gas Chromatography, Ultraviolet (UV) and Infrared (IR) spectroscopy, Karl Fischer titration, and dissolution
- Strong chemistry knowledge
- 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)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days