Merck
Sr. Scientist, Small Molecule Analytical Chemistry
Merck, West Point, Pennsylvania, us, 19486
Senior Scientist
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 and West Point, PA sites. The successful candidate will utilize innovative analytical characterization technologies to drive late-stage small molecule 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 the following areas: separation techniques and mass spectrometry. Strong fundamental knowledge in recent advances in analytical technologies 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 or MS in Analytical Chemistry or related discipline with at least 5+ 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. 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
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 and West Point, PA sites. The successful candidate will utilize innovative analytical characterization technologies to drive late-stage small molecule 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 the following areas: separation techniques and mass spectrometry. Strong fundamental knowledge in recent advances in analytical technologies 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 or MS in Analytical Chemistry or related discipline with at least 5+ 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. 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