艾玛 specializes in extractables and leachables (E&L) studies with more than 40 peer reviewed publications. She has more than 11 years of research experience in the scientific community, successfully moving from academia to industry.

经验

艾玛 earned a Ph.D. in Neuroscience from Indiana University and launched her industry career as an Analytical Chemist at im体育APP Ann Arbor. Leveraging previous LC-MS/MS expertise, she expanded her toolkit to include other mass spectrometry techniques, contributing to Extractables and Leachables (E&L) studies. In just a few years, 艾玛 transitioned to leadership and was promoted to Manager of Advanced Analytics.

Working to ensure medicines are safe and accessible, the Advanced Analytics department specializes in E&L and mass spectrometry methods under both R&D and cGMP quality systems. The group runs complete programs, seeing a study through from early development, to validation, and finally to stability sample testing. Her team has over 99% on-time delivery, contributing to FDA approvals for life-saving drugs.

艾玛 is based at im体育APP Ann Arbor, but works closely with all of the Life Sciences labs across the Americas. 

Career highlights

  • Authored over 40 peer-reviewed publications based on LC-MS/MS work; subsequently applied mass spectrometry skills to extractables and leachables (E&L) studies
  • Successfully transitioned from academia to industry, then from a Chemist to team leader
  • 10 invited conference talks (3 for E&L), including international meetings, and experience chairing scientific sessions
  • Delivered ~$4 million in revenue in the last year with over 99% on-time delivery
  • Designed and oversaw E&L studies contributing to FDA approvals
  • Co-inventor of a chemical denaturant for controlled medications (US Patent 10668312)
  • Developed and implemented platform strategies for organic impurities such as mycotoxins and nitrosamines
  • Winner of Operational Collaborator, Scientific Excellence, Client-Centricity, and On-Time All the Time Awards

Specializations

  • Extractables and Leachables (E&L)
  • ENDS (Electronic 尼古丁 Delivery 系统s)
  • Pharmaceutical Analytical Method Development
  • im体育APPal Impurity & 分析 
  • Stability Storage & 测试

Professional qualifications

  • Ph.D. in Neuroscience from Indiana University
  • Bachelor of Science from Indiana University, with distinction
  • Member of Cannabinoid Research Society

Sector expertise

  • Pharmaceuticals
  • 尼古丁

Connect with 艾玛 on LinkedIn

 

Overcoming challenges in analytical method development for colloidal oatmeal OTC monograph products

Overcoming Challenges in Analytical Method Development For Colloidal Oatmeal OTC Monograph 产品s

With years of proven success in developing, validating, and releasing OTC products with complex and challenging active ingredients and matrices, including colloidal oatmeal, im体育APP is the partner of choice for leading OTC product developers and manufacturers. 

Learn more about our development of OTC colloidal oatmeal in the article linked below.

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