Job Description

Responsibilities:

  • Lead and manage sterile manufacturing operations, including formulation, filling, and aseptic processing
  • Oversee daily production activities to ensure alignment with cGMP, FDA, and regulatory requirements
  • Drive operational performance, including throughput, efficiency, and right-first-time execution
  • Provide leadership, coaching, and development for manufacturing staff and supervisors
  • Partner cross-functionally with QA, QC, Engineering, and Validation teams
  • Support and lead investigations, including deviations, CAPAs, and root cause analysis
  • Ensure inspection readiness and actively participate in regulatory audits
  • Identify and implement continuous improvement initiatives across operations
  • Requirements:

  • Bachelor’s degree in a scientific or engineering discipline
  • 7+ years of pharmaceutical manufacturing experience, with a strong focus on aseptic/sterile operations
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