Ultragenyxpharmaceutical

Associate Director, Production and Manufacturing Excellence

Bedford, MA · Director

Sponsorship not specifiedDetected 8 hours ago
Process ImprovementGMPCRISPRLeadershipCollaborationProblem SolvingLean Manufacturing

About the role

  • ultra innovative - Tackle rare and dynamic challenges
  • This role ensures robust, compliant, and inspection-ready execution of deviations, investigations, and CAPAs while advancing operational excellence through standardized production systems, performance metrics, and cross-functional projects and programs.
  • The position serves as a member of the Manufacturing Leadership Team, driving alignment, performance, and continuous improvement across Manufacturing, site-based Technical Operations, and Quality.

Responsibilities

  • Build and enhance partnership with key stakeholder groups such as Quality and MSAT supporting multiple sites including external manufacturing to share best practices and drive continuous improvement
  • Drive system-level improvements to enhance process robustness and reduce recurrence of deviations
  • Lead implementation operational excellence initiatives using Lean Manufacturing, Six Sigma, and structured problem-solving methodologies
  • Contribute to developing strategy and governance for Manufacturing Excellence encompassing:
  • Build, develop, and lead a high-performing team while fostering a culture of accountability, collaboration, and continuous improvement
  • Contribute to developing strategy and governance for

Requirements

  • Bachelor's degree in science, engineering, or related field required
  • 10+ years of experience in biopharmaceutical, biotechnology, or gene therapy manufacturing and 7+ years of management experience.
  • Deep knowledge of GMP regulations and their application in biologics or gene therapy manufacturing
  • Proven experience driving operational excellence, continuous improvement, and large-scale process transformation
  • Expertise in root cause analysis and structured problem-solving methodologies (e.g., 5 Whys, Fishbone, Is/Is Not)

Nice to have

  • Experience with electronic quality systems (e.g., Veeva Vault) preferred

Benefits

  • To achieve this goal, our vision is to lead the future of rare disease medicine.
  • For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments.
  • We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside of work.
  • Lead preparation for regulatory inspections and represent Technical Operations during health authority interactions for quality systems records.

Company info

  • At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do.
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