Associate Principal Scientist, Analytical Chemistry - Inhalation Product Development

Merck Merck · Pharma · NJ

Seeking an Associate Principal Scientist with deep knowledge and experience in inhalation product development and characterization to drive late-stage pharmaceutical drug product development and commercialization using innovative analytical characterization technologies. Responsibilities include analytical method development and validation, drug product testing, manufacturing process characterization, stability studies, specification development, CMC documentation, and regulatory support within a cGMP environment. Requires expertise in separation techniques, aerosol science, and common analytical techniques like UHPLC/HPLC and GC.

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. Experience with inhalation product development, characterization and testing including aerodynamic particle size distribution (APSD), delivered dose uniformity (DDU), metered dose uniformity (MDU) and particle size distribution (PSD)
  5. 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

Skills

Required

  • Analytical Chemistry
  • Analytical Development
  • Chemical Synthesis
  • Computational Chemistry
  • Dry Powder Inhalers (DPI)
  • Gas Chromatography Analysis
  • Gas Chromatography-Mass Spectrometry (GC-MS)
  • High-Performance Liquid Chromatography (HPLC)
  • Inhalers
  • Karl Fischer Titrations
  • Lead Optimization
  • Product Development
  • Spectrophotometry
  • inhalation product development
  • characterization and testing
  • aerodynamic particle size distribution (APSD)
  • delivered dose uniformity (DDU)
  • metered dose uniformity (MDU)
  • particle size distribution (PSD)
  • Ultrahigh/High Performance Liquid Chromatography (UHPLC/HPLC)
  • Gas Chromatography
  • Ultraviolet (UV) and Infrared (IR) spectroscopy
  • Karl Fischer titration
  • dissolution
  • chemistry knowledge
  • problem solving ability
  • verbal and written communication skills
  • creativity
  • interpersonal skills
  • work in a team environment
  • cross-functional interactions

Nice to have

  • method development and validation
  • authoring relevant CMC sections of regulatory submissions

What the JD emphasized

  • inhalation product development
  • analytical characterization technologies
  • cGMP environment
  • inhalation product development, characterization and testing