Senior Manager, QC Technical Operations

ElevateBio
Pittsburgh
Workplace: OnsiteFull timeFunction: Quality & Regulatory (Non-Software)Experience: 8+ yearsSkills: ["Communication","Independent work","Organizational skills","Leadership"]

Lead Quality Control execution for a new Pittsburgh facility, owning QC procedure revisions and supporting GMP-ready documentation and training. Partner with MSAT on tech transfer onboarding, help develop compliant laboratory systems, and oversee data review, deviations/OOS/OOT investigations, and inspections readiness. This role starts with site startup activities (including establishing microbiology) and transitions to managing QC functions, including logistics, outsourcing, mentoring, and on-floor support as needed.

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ElevateBio
ElevateBio
2 days ago

Senior Manager, QC Technical Operations

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

Job Summary

Lead Quality Control execution for a new Pittsburgh facility, owning QC procedure revisions and supporting GMP-ready documentation and training. Partner with MSAT on tech transfer onboarding, help develop compliant laboratory systems, and oversee data review, deviations/OOS/OOT investigations, and inspections readiness. This role starts with site startup activities (including establishing microbiology) and transitions to managing QC functions, including logistics, outsourcing, mentoring, and on-floor support as needed.
Location: Pittsburgh
Workplace: Onsite
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Manager level

Key Responsibilities

  • •Own QC procedure revisions to reflect desired business processes, and support/review functional documentation including protocols and reports.
  • •Partner with MSAT on plans for initial tech transfer support and program onboarding.
  • •Develop, implement, and maintain laboratory systems compliant with applicable GMP practices and regulations.
  • •Support planning and implementation of site training programs, including EM and aseptic programs.
  • •Review, trend, and present data; oversee lab excursions (deviations, OOS, OOT, and atypical investigations) and participate in regulatory inspections and facility audits.

Key Requirements

  • •Bachelor’s degree with at least 8 years of experience, OR Master’s with 6 years, OR PhD with at least 4 years.
  • •Experience supervising teams of people.
  • •Experience with clean room qualification per ISO 14644.
  • •Experience with compendial safety testing and rapid methodologies (BacT).
  • •Experience with gene and cell therapy test methodologies (qPCR/ddPCR, Flow Cytometry, ELISA, and cell-based assays).
Experience:8+ yearsGMPCell and gene therapy manufacturingLaboratory investigationsClean room qualification
Skills:CommunicationIndependent workOrganizational skillsLeadership
Languages:English
Tech Stack:GMPSOPsLIMSCMMSQMSERPISO 14644BacTQPCRDdPCRFlow CytometryELISA

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