Associate Principal Scientist, Analytical Chemistry - Inhalation Product Development
MSD•Upper Gwynedd Township, PA
•Hybrid
About The Position
The Analytical Commercialization Technology (ACT) group within Analytical Chemistry in Development and Supply (ACDS) is seeking applicants for an Associate Principal Scientist position available at the Rahway, NJ and West Point, PA sites. The successful candidate will utilize innovative analytical characterization technologies to drive late-stage pharmaceutical drug product development and commercialization. The Associate Principal Scientist position is seeking applicants with deep knowledge and experience in inhalation product development and characterization.
Requirements
- 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
- 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
- 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
Nice To Haves
- Experience with method development and validation
- Familiarity with authoring relevant CMC sections of regulatory submissions
- Knowledge and proficiency in separation techniques and aerosol science
- Prior experience with inhalation product development, analytical testing and characterization
Responsibilities
- 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
Benefits
- medical
- dental
- vision healthcare
- other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
Ph.D. or professional degree
