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 West Point, PA and Rahway, NJ sites. The successful candidate will utilize innovative analytical characterization technologies to drive late-stage pharmaceutical drug product development and commercialization. The Associate Principal Scientist responsibilities include, but not limited to, 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, and responses to regulatory questions. The successful candidate must be able to collaborate in a dynamic, integrated, and multidisciplinary team environment.
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
Requirements
- Master of Science (MS) in Analytical Chemistry or related discipline with seven (7) years of relevant pharmaceutical and analytical development experience
- OR PhD in Analytical Chemistry or related discipline with three (3) years of relevant pharmaceutical and analytical development experience
- 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
Nice-to-haves
- Experience with hyphenated analytical techniques such as LC/MS and GC/MS with proven ability in troubleshooting these methodologies
- Experience with method development and validation
- Familiarity with authoring relevant CMC sections of regulatory submissions
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
