Associate Principal Scientist, Chemistry

** Job Description
**** Associate Principal Scientist, Analytical Commercialization Technology
** 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 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 the following areas: separation techniques and aerosol science. Prior experience with inhalation product development and characterization is highly desired. Applicants must have effective organizational skills, multi-tasking, oral and written communications skills.
** Education

Minimum 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.
** Required

Experience and Skills:

*** 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
* Experience with inhalation product characterization including aerodynamic particle size distribution (APSD), delivered dose uniformity (DDU), metered dose uniformity (MDU) and particle size distribution (PSD)
* 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
** Preferred

Experience and Skills:

*** 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
*
* Required Skills:

** Analytical Chemistry, Analytical Development, Chemical Biology, Chemical Processing, Chemical Synthesis, Chromatography, Computational Chemistry, Data Analysis, Enzymology, Experimental Development, Gas Chromatography Analysis, Gas Chromatography-Mass Spectrometry (GC-MS), High-Performance Liquid Chromatography (HPLC), Infrared Spectroscopy, Karl Fischer Titrations, Machine Learning (ML), Molecular Structure, Pharmaceutical Development, Spectrophotometry, Synthetic Chemistry
** Preferred

Skills:

** Current Employees apply

Current Contingent Workers apply
** US and Puerto Rico Residents Only:
** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

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