QC Manager

  •  

Cambridge, MA

Industry: Biotech/Pharma

  •  

11 - 15 years

Posted 255 days ago

  by    Breeana Cebula

This job is no longer available.

Mid-Size Biologics company here in Cambridge, MA is growing and looking to add a QC Manager - Lab Operations to their Team! QC Manager will work closely with QC Leadership and support the build-out of a new commercial-level, in-house GMP Sample Control and testing laboratory! This lab will support the release and stability for multiple stages of gene therapy and immune oncology products. Otherresponsibilities include:

  • Manage and build Sample Control for GMP Release, Stability, Extra Test Samples
  • Establish GMP Reference Standard/Assay Control and Critical Reagents Inventory Control and manage Consumables/Reagents
  • Lead and/or review Equipment/Instrument IOQ/PQ (vendor/company)
  • Manage and prepare POs for GMP CTO Release Testing
  • Coordinate Release, and Stability cGMP analytical Testing and Review for Appearance, pH, bioassay, flow cytometry, qPCR, HPLC, and ELISA)
  • Author, review, and/or approve SOPs/policies and technical reports
  • Implement and manage equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, lab cleaning, cGMP documentation, LIMS
  • Participate and/or lead in providing the necessary information for regulatory filings and inspections.
  • Lead and support CAPA/Continuous Improvement Initiatives

Requirements:

  • BS or MS in a scientific discipline, 10+ years of related experience in QC GMP testing
  • cGMP operational and technical background in cell biology, biochemistry, and/or molecular biology
  • Experience with implementation/managing QC GMP equipment/instrument annual performance verification/calibration/maintenance, monitoring, alarm notification, and qualification, data back-up; data archival of analytical data

$115K - $149K