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Director of Manufacturing

Director of Manufacturing

LocationMassachusetts, United States
Business SectorBiotechnology
Contact nameAliyana Darwesh
Contact email
Job ref21405
Published5 months ago
Director of Manufacturing

Currently working with a Global Biotech Client who are in need of support from a Director of Manufacturing in Massachusetts, U.S. This is an opportunity to work with a global leader in Cell and Gene therapy transforming healthcare with ground-breaking technology.
Interview + offer will take place this week and next, so get in touch ASAP if interested.

  • Ensure site manufacturing activities are scheduled and run in accordance with company goals and objectives.
  • Certifies pharmaceutical product is manufactured in a timely and compliant manner according to GMP requirements for clinical trials of IND and approved NDA materials. 
  • Review manufacturing process performance data to assess if processes are operating as expected.
  • Collaborates with Process Development, Engineering and MSAT for the transfer and implementation of new technologies.
  • Ensures departmental plans and resources are efficiently utilized so products are produced in accordance with planned manufacturing batch production schedules. 
  • Participates in development of operating plans and budgets 
  • Supports development of CMC regulatory filings related to the Manufacturing facility.
  • Responsible for continuous improvement and prioritization of Quality efforts in order to ensure compliance.
  • Creates vision and inspires team on a unified operating strategy to ensure short and long term success.
  • Set goals and objectives to for organization in alignment with supporting functions.

  • BS in scientific discipline
  • 10+ years of relevant experience in a manufacturing environment, preferably a biopharma discipline
  • 8+ years of experience in managing an operations group or equivalent
  • Solid understanding of quality fundamentals, quality control, and quality management systems
  • Experience in internal and external audits

Position: Director of Manufacturing
Location: MA, United States
Start Date: Immediately or by agreement