Senior Scientist, Analytical Chemistry

Merck Merck · Pharma · NJ

Senior Scientist in Analytical Chemistry at Merck, focusing on late-stage pharmaceutical drug product development and commercialization. Responsibilities include analytical method development and validation, drug product testing, investigations in a cGMP environment, characterization, stability studies, specification development, scale-up support, and CMC documentation for regulatory submissions. Requires PhD in Analytical Chemistry or related discipline and extensive experience with common analytical techniques like HPLC, GC, UV/IR spectroscopy, Karl Fischer titration, and dissolution.

What you'd actually do

  1. utilize innovative analytical characterization technologies to drive late-stage pharmaceutical drug product development and commercialization
  2. 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
  3. collaborate in a dynamic, integrated, and multidisciplinary team environment
  4. knowledge and proficiency in separation techniques and strong fundamental knowledge in recent advances in analytical technologies
  5. effective organizational skills, multi-tasking, problem solving, and oral and written communications skills

Skills

Required

  • PhD in Analytical Chemistry or related discipline
  • 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 have

  • Experience with method development

What the JD emphasized

  • cGMP environment
  • analytical method development
  • drug product development
  • analytical investigations
  • manufacturing process scale-up
  • regulatory submissions