Analytical Development Scientist
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.