Senior Scientist, 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.


What is expected of you for success in your role

  • Demonstrates depth and breadth of knowledge within respective scientific discipline and recognizes interrelationships of other scientific disciplines
  • Applies in-depth scientific knowledge and skills within respective discipline to complex assignments and across other disciplines
  • Develops and implements strategies for addressing a wide variety of project needs
  • May manage Senior Scientists or supervisors with primary focus on scientific output
  • Identifies emerging technologies and instrumentation and makes recommendation for business application
  • May be responsible for managing intellectual property portfolio in own discipline and monitor the intellectual property landscape
  • Identify direction for research to be conducted
  • Negotiation and resolution of customer issues
  • Anticipate optional paths for the customer to help identify alternative solutions


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

  • Performs cGMP audits of active pharmaceutical ingredient and drug product manufacturers, and contract laboratories, domestically and internationally
  • Perform remote quality assurance support – auditing of manufacturing production and testing records; protocols and data sets
  • Authors and reviews CMC documents for INDs, NDAs, ANDAs, BLAs, Drug Master Files, and other similar global regulatory applications
  • Manages assembly of global regulatory applications including extraction of pertinent CMC information from global regulatory databases
  • Authors and reviews documents associated with global pharmaceutical product development
  • Maintains good client relationships Ensures an established level of billable hours per fiscal year


Qualifications

  • MS/BS in Chemistry, Analytical Chemistry or related life sciences
  • At least 10 years’ experience in support of pharmaceutical product development, quality assurance and/or CMC regulatory affairs, highly preferred
  • Good understanding and application of scientific principles and techniques used in pharmaceutical product development
  • In-depth knowledge and experience with cGMP regulations and ICH guidance’s.
  • Experience with development of small and/or large molecules (experience and expertise with large molecules, formulation/product development, medical device, or animal health is additionally beneficial)
  • Experience with writing global regulatory applications in eCTD format
  • Passport required
  • Up to 25% travel required performing audits, including internationally (primary international locations include China, Japan, Europe, but may include other areas)