Senior Scientist, Chemistry, Manufacturing & Controls (CMC)

What Scientific Consulting contributes to Cardinal Health

**Remote from home**

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.

What is expected of you for success in your role

  • Demonstrates in-depth knowledge of respective scientific discipline and familiarity with related scientific disciplines
  • Typically PhD level or with equivalent experience Independently applies scientific knowledge and skills within respective discipline to a variety of assignments
  • Develops and implements detailed experimental plans for non-standard situations
  • Provides guidance to other Scientists and may supervise direct reports
  • Leads the innovative efforts and advancing the organziation's intellectual property within own projects
  • Present and publish research findings in conferences and peer review journals
  • Directly interfaces with customers on a regular basis
  • Supports business development activites
  • Works to understand customer needs and makes recommendation

What is expected of you and others at this level in Research for functional success

  • Works to understand complex functional situations by paying attention to the details of the tasks at hand and by breaking them down into smaller pieces
  • Proactively develops and maintains broad knowledge of the technical disciplines in own functional area(s); applies broad knowledge of trends and
  • Demonstrates deep customer expertise; collaborates with appropriate parties to identify the drivers leading to business success.
  • Encourages informed Risk-taking and acts as a catalyst for innovation at Cardinal Health;
  • generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources.
  • Proactively develops and maintains technical knowledge in specialized area(s), remaining up to date on current trends and best practices

Accountabilities in this role

• 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

  • Bachelor's degree required
  • Minimum 4 years 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
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"Chicago Metro Area, Philadelphia Metro Area"

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