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Manufacturing Operations Lead

Full-Time Middleton, United States
Health & Biotech
Health & Biotech
23 July 2025
Description
  • Provide mentorship and coaching to develop a high performing teams of engineers and technical managers who support different commercial products in two different facility within the Rockville site
  • Proactively works with colleagues in manufacturing, engineering and quality to provide technical solutions to complex questions related to DS bioprocessing
  • Establish plans for hands-off between manufacturing, engineering and MSAT
  • Ensures implementation of technically sound CAPA in collaboration with colleagues in quality, manufacturing and engineering
  • Manages the Change Control MSAT portfolio, provide technical oversight to deviations and product impact assessment to enable prompt resolution and prevent reoccurrence
  • Support RCA and DMAIC exercises during investigation or in support of business processes improvements
  • Identify and implement continuous improvement (including yield improvements, enabling aseptic operations)
  • Effectively deploys resources to troubleshoot and mitigate on the floor issues as needed, support campaign restart and shutdown
  • Owns and drives site feasibility assessment to evaluate introduction of new assets into the site
Qualifications
  • Bachelors degree
  • 15+ years of experience in biopharmaceutical process development, MSAT or CMC roles
  • Experience with current trends in the industry, ICH Guidelines and GMP principles at commercial scale
  • Experience with CAPA, Change Controls and Deviation supports
  • Prior experience with operational excellence principles and business processes improvements
  • Experience and understanding of bioprocessing principle for DS bioprocesses: able to troubleshoot processes both for upstream and downstream

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