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Senior Clinical Manufacturing Operations Lead

2 months ago

North Chicago Illinois, United States AbbVie Full time
Job Summary

AbbVie is seeking a highly skilled Senior Clinical Manufacturing Operations Lead to lead production teams in the production of high-quality solid dosage form clinical supplies utilizing state-of-the-art technologies.

Key Responsibilities:
  • Operations Management: Lead manufacturing activities, including the preparation and close-out of batch records, ensuring minimal errors and timely completion of manufacturing activities according to the established schedule.
  • Supervision: Supervise pilot plant technicians, including daily scheduling of activities, managing personnel development, holding technicians accountable against performance expectations, and writing and delivering performance reviews.
  • Formulation Development: Collaborate with formulators on formulation development and research activities occurring in the pilot plant, providing key pilot plant capabilities insight on these activities.
  • Technical Support: Possess detailed knowledge of pilot plant equipment and processing capabilities, providing technical guidance to manufacturing personnel, and leading trouble-shooting and identifying solutions to issues that arise during manufacturing.
  • Compliance: Understand and follow cGMP requirements, established policies, and conduct business activities with minimal deviations or exceptions.
  • Project Coordination: Work with the CMC team and other supporting areas to assure project commitments are met, including providing draft batch records for review, assuring material availability, and preparing cleaning documentation.
  • Communication: Record, tabulate, and report results within the group or team using necessary tools, and report significant issues to management with appropriate sense of urgency.
  • Leadership: Direct activities of manufacturing technicians in a matrix environment.