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Analytical Development Scientist

October 26, 2020

We are searching for a new Analytical Development Scientist. Regis is a contract manufacturer of small molecule APIs for small, mid-size and large pharmaceutical companies.

 

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 Regis Technologies 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

 

The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

If you would like to become a vital part of our organization and enjoy a competitive salary with comprehensive benefits, please apply. EOE

Contact: Christine Soulje, Ph.D., Director of Analytical Development
csoulje@registech.com
Regis Technologies Inc.
8210 Austin Avenue
Morton Grove, IL 60053

NO PHONE CALLS PLEASE.

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