Senior Scientist, Chemistry
About The Position
Senior Scientist, Analytical Commercialization Technology The Analytical Commercialization Technology (ACT) group within Analytical Chemistry in Development and Supply (ACDS) is seeking applicants for a Senior Scientist position available at the Rahway, NJ site. The successful candidate will utilize innovative analytical characterization technologies to drive late-stage pharmaceutical drug product development and commercialization. The Senior 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. The ideal candidate will have knowledge and proficiency in separation techniques and strong fundamental knowledge in recent advances in analytical technologies. Applicants must have effective organizational skills, multi-tasking, oral and written communications skills. Education Minimum Requirements: PhD in Analytical Chemistry or related discipline or MS in Analytical Chemistry or related discipline with at least 5+ years of relevant pharmaceutical development experience.
Requirements
- 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 or MS in Analytical Chemistry or related discipline with at least 5+ years of relevant pharmaceutical development experience
Nice To Haves
- Experience or foundational knowledge in aerosol science including analytical techniques to characterize aerosols
- 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
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
- collaborate in a dynamic, integrated, and multidisciplinary team environment
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays, vacation, and compassionate and sick days
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
Number of Employees
5,001-10,000 employees
