Scientist II, Chemistry, Manufacturing & Controls (CMC)

What Scientific Consulting contributes to Cardinal Health

Scientific Consulting is responsible for Pharmaceutics, Chemistry, Microbiology and other Biotechnology and Life-science related disciplines performing basic and applied research to provide innovative solutions for internal and customer funded projects.

Accoutabiities in this roles

• Manages assembly of regulatory information for submission
• Adheres to the client's defined submission preparation timelines
• Searches document and change management databases for historical data/information that need to be
captured in the updated regulatory submission.
• Using the client's templates for dossier sections, author CMC sections for routine submissions (e.g.,
clinical trial amendments, Type I variations, IND/NDA/BLA annual reports, CMC renewals), including
adding technical data and descriptive text
• Collaborate with Data Verification Specialist to have submission content verified
• Liaise with Senior Submission Preparation resource to have work product reviewed

Qualifications

  • MS/BS in Chemistry /Pharmaceutics with related science experience preferred
  • 2 years of related experience
  • Foundation in general scientific practice and in the principles and concepts of a discipline (e.g.,
    chemistry, pharmaceutical science, pharmacy, biology, microbiology etc.)
  • Sound knowledge of several aspects of regulatory principles, practices and concepts applicable to
    preparing regulatory submissions
  • Rudimentary understanding of drug development or manufacturing/improvement processes
  • Understands regulatory merits for scientific/technological development or manufacturing activities

What is expected of you and others at this level

  • Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks
  • Works on projects of moderate scope and complexity
  • Identifies possbile solutions to a variety of technical problems and takes actions to resolve
  • Applies judgment within defined parameters
  • Receives general guidance may receive more detailed instruction on new projects
  • Work reviewed for sound reasoning and accuracy