Senior Manager, Manufacturing

ElevateBio
Pittsburgh
Workplace: OnsiteFull timeFunction: Manufacturing & Production OperationsExperience: 4+ yearsSkills: ["Cross-functional leadership","Team supervision","Data analysis","Process improvement","Regulatory readiness"]

Own the startup execution for a new manufacturing facility in Pittsburgh, driving procedural changes, digital systems, and business processes to enable clinical and commercial manufacturing for US and EU markets. Manage GMP-focused documentation, training, metrics, investigations, and functional projects, partnering with MSAT on tech transfer and onboarding. Review and present manufacturing performance data, oversee deviation investigations, support inspections, and lead hiring and onboarding for the site manufacturing team.

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FursaFursa
ElevateBio
ElevateBio
2 days ago

Senior Manager, Manufacturing

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Source: Company careers pageValidated by: Fursa AI
Last checked: 13 hours agoStatus: Live

Job Summary

Own the startup execution for a new manufacturing facility in Pittsburgh, driving procedural changes, digital systems, and business processes to enable clinical and commercial manufacturing for US and EU markets. Manage GMP-focused documentation, training, metrics, investigations, and functional projects, partnering with MSAT on tech transfer and onboarding. Review and present manufacturing performance data, oversee deviation investigations, support inspections, and lead hiring and onboarding for the site manufacturing team.
Location: Pittsburgh
Workplace: Onsite
Employment Type: Full time
Job Function: Manufacturing & Production Operations
Seniority: Sr. Manager level

Key Responsibilities

  • •Own manufacturing procedure revisions to reflect desired business processes and support/review functional documentation.
  • •Represent manufacturing in digital system and equipment design and implementation projects.
  • •Partner with MSAT on tech transfer plans and program onboarding.
  • •Support planning and implementation of site training programs and EM/aseptic programs.
  • •Oversee manufacturing deviation investigations and participate in regulatory inspections and facility audits.

Key Requirements

  • •Bachelor’s (8+ years) OR Master’s (6+ years) OR PhD (4+ years) in a related field.
  • •Experience supervising teams of people.
  • •Extensive manufacturing experience in a GMP facility supporting complex products (autologous/allogeneic cell therapies or gene therapies is a plus).
  • •Demonstrated ability to lead cross-functional teams in a matrixed organization.
  • •Experience with facility startup is a plus.
Experience:4+ yearsGMPCell therapiesGene therapies
Skills:Cross-functional leadershipTeam supervisionData analysisProcess improvementRegulatory readiness

Company Brief

ElevateBio
Develops and manufactures cell and gene therapies and provides integrated biologics development and manufacturing platforms, partnering with biotech companies to accelerate clinical and commercial production of advanced therapies.
Industry: Biotech
Company Size: Large (251 to 1,000 employees)
Growth: Established Company
Headquarters: Cambridge, United States
Founded: 2017
WebsiteLinkedIn