R&D Chemist

6/7/21

Morton Grove, IL 60023

1260

FullTimeRegular

RESPONSIBILITIES:
  • Develop analytical testing strategies based on provided customer technical package and/or process development synthetic routes
  • Develop new analytical methods
  • Assess customer methods for validation readiness
  • Execute method validation protocols for the CGMP release of drug substance batches
  • Author reports and review data
  • Collaborate with customers and other functional areas to advance projects through development
  • Provide analytical technical assistance to Quality Control and Process Chemistry areas
  • Assure compliance with safety, quality, and regulatory policies and government regulations
  • Selected candidate will report to the Director of Analytical Method Development
PRIMARY ACTIVITIES:
  • Independently generate precise, reliable and reproducible data in a timely manner as part of the development, validation, and transfer of drug substance analytical methods
  • Make fact-based decisions utilizing literature and analytical data as available
  • Execute analytical development against project timelines
  • Transfer analytical methods to the Quality Control Group
  • Ensure the development of strategies that improve the future capabilities and productivity of the greater organization

REQUIREMENTS:
  • Required laboratory skills include strong working knowledge of HPLC, GC, MS, and titration techniques, troubleshooting ability, working independently, and attention to detail
  • Ability to read, analyze and interpret professional journals, technical procedures, or governmental regulations; ability to write reports, business correspondence and procedure manuals; ability to effectively present information and respond to questions from colleagues or managers, customers and the general public
  • Ability to perform complex method development and suggest appropriate method modifications
  • Ability to effectively analyze data and/or problems, and ability to define problems, collect data, establish facts, and draw valid conclusions; ability to interpret an extensive variety of technical data and deal with several abstract and concrete variables
  • Basic computer knowledge is desired
  • Experience with ICP-MS, Chromeleon Chromatography Data Software, solid state or polymorph characterization a plus
  • Education/Experience: BS, Chemistry with a minimum of 5 years experience in Analytical Development; or MS, Chemistry with a minimum of 3 years experience in Analytical Development; or PhD, Chemistry with a minimum of 2 years experience in Analytical Development
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