Scientist II, Chemistry, Manufacturing & Controls (CMC)
About the Job
_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 topreparing 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 Cardinal Health is an Equal Opportunity/Affirmative Action employer\. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status\.