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Manager, Manufacturing

PCI Pharma Services · Bedford, NH

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Role summary

PCI Pharma Services seeks a Manufacturing Manager to oversee all manufacturing operations at a Bedford, NH facility, directing staff and ensuring compliance with cGMP standards across aseptic, non-aseptic, and lyophilization activities. The role includes batch documentation oversight, process validation support, and cross-functional collaboration with quality and facilities teams.

What they're looking for

  • Proficiency in pharmaceutical process development for aseptically produced products or medical device manufacturing
  • Working knowledge of pharmaceutical facilities, lyophilization technology, and cleanroom manufacturing equipment
  • Strong troubleshooting and root cause analysis skills with structured problem-solving methodology
  • Demonstrated leadership experience managing operations staff and coordinating complex projects
  • Excellent written and oral communication skills, particularly for technical reporting and client interaction
  • Knowledge of cGMP regulations, SOPs, batch record documentation, and pharmaceutical quality systems

What you'll be doing

  • Direct manufacturing staff and oversee continuous operation of drug product and device manufacturing lines
  • Ensure compliance with cGMP, regulatory guidelines, and all applicable SOPs in cleanroom and production areas
  • Lead safety initiatives and oversee batch record documentation, deviation reports, investigations, and CAPA activities
  • Support production scheduling, staffing coordination, equipment maintenance, and process validation activities
  • Manage training of operators in aseptic techniques, contamination control, formulation, and packaging procedures

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Date posted1 day ago
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