Senior Manager, Clinical Product Supply (CMC)

Lake County, IL, US
Sep 21, 2019
Required Education
Bachelors Degree
Position Type
Full time
The Senior Manager, Clinical Product Supply (CMC) is primarily responsible for ensuring the successful and timely release of Good Manufacturing Practice (GMP) clinical supplies by providing direction and oversight of the overall manufacturing, testing and release processes from drug substance to drug product to finished product

Key Responsibilities Include :

  • Serve as the quality assurance (QA) point of contact in CMC and Supply Chain meetings and direct QA functional areas to facilitate the approval of drug to clinical trials to meet project timelines.
  • Provide management of clinical supply product actions and recalls.
  • Support in-licensing and collaboration activities.
  • Ensure suitable quality agreements or quality aspects of contracts are in place between Research and Development (R&D) and third party manufacturers, third party laboratories, other service providers and other sites.
  • Support the preparation of regulatory inspections and internal audits, and represents GMP Quality in inspections and audits.
  • Interact and influence decisions of the various R&D Directors and Vice Presidents as well as external customers and mentor Quality Engineers.
  • Provide consultation & training on QA specific items to internal and cross-functional groups
  • Lead complex global cross-functional process improvement teams.
  • Work on unusually complex technical problems and provide solutions that are highly innovative and ingenious; resolve project team issues with minimal oversight.
  • Review and approve extemporaneous dose preparation instructions.

  • Bachelor's degree or equivalent experience is required; typically in life sciences, engineering
  • Minimum 6+ years of industry experience in Quality Assurance, drug development or other healthcare related field; less experienced considered with advanced degree
  • Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide requirements for GMP is required.
  • Knowledge of regulatory compliance requirements should include historical perspectives and current trends of the regulatory agencies as they apply to the clinical pharmaceutical and chemical manufacturing processes.
  • Good communications skills
  • Must have leadership skills and have been seen to take a position on quality issues and standards, and must be capable of clearly and logically justifying such positions.
  • Other competencies are required, e.g., making difficult decisions, relationship-building, influencing, fostering teamwork, knowledge of the business and sound judgment.