Associate Director for Data Strategy contributing to real - world evidence with advanced analytics and partnerships. Driving innovative projects in healthcare decision - making and data science in a collaborative environment.
About the role
- Associate Principal Scientist utilizing innovative analytical technologies for pharmaceutical drug product development at a global healthcare leader. Collaborating in a multidisciplinary team environment for key deliverables.
Responsibilities
- 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)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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