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Colorado State University

Associate Director of Manufacturing Operations

🇺🇸 Fort Collins, CO

🕑 Full-Time

💰 $130K - $170K

💻 Operations

🗓️ July 17th, 2025

Edtech.com's Summary

Colorado State University is hiring an Associate Director of Manufacturing Operations. This role leads the operational, technical, and regulatory aspects of cGMP biopharma manufacturing campaigns, focusing on producing early phase clinical materials. The position involves managing interdisciplinary projects, ensuring compliance with FDA regulations, and overseeing high-containment biosafety manufacturing processes.

Highlights

  • Lead BioMARC cGMP biomanufacturing operations including upstream and downstream activities for pre-clinical and clinical material production.
  • Manage production schedules, facility and staff planning, and coordinate technical manufacturing functions under regulatory requirements.
  • Develop and implement cGMP procedures, troubleshoot manufacturing deviations, and ensure quality compliance.
  • Build, train, and mentor skilled teams in compliance and continuous improvement practices.
  • Collaborate cross-functionally with Facilities, Process Development, QA/QC, and other CSU groups.
  • Ensure adherence to FDA cGMP Quality Management Systems and participate in risk management and audits.
  • Must have experience with BSL-2/BSL-3 containment, viral vaccine cGMP production, mammalian cell culture, viral propagation, bacterial fermentation, filtration, and chromatography.
  • Required qualifications include a BS, MS, or PhD in biological sciences or engineering with extensive relevant work experience, and proven cGMP manufacturing management experience.
  • Preferred skills include process development, technology transfer, equipment scale-up, and experience with Tier 1 Select Agents.
  • Annual salary range is $130,000 to $170,000 with comprehensive CSU benefits included.