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Director, Quality Control - Gene Therapy

  • Job type: Permanent
  • Location: New York
  • Salary: $150000 - $200000 per annum
  • Job reference: MERZ051418954
  • Sector: Quality Control, EPM Scientific, Quality
  • Date posted: 15/05/2018
  • Biotechnology – Gene Therapy
  • NYC
  • $150,000 - $200,000 + Bonus + Benefits + Excellent Career Growth
A rapidly expanding Biotech company located in the heart of NYC is urgently seeking an experienced
Director, Quality Control. This person would report to the Head of Development leading the QC team in support of the success for the gene therapy programs. The QC Director should have at least 4 years of experience working with viral vector gene therapy development programs within the biotech industry. This individual will ensure that CMOs are in alignment with the company and regulatory GMP compliance expectations, and overlook QC testing processes and programs in support of GMP manufacturing.

 This is a new role and will be tailored around their ideal candidate!

The Director, Quality Control will be responsible for the following duties:
  • Establish Investigations, SOPs, Deviations and CAPA implemention for GMP facilities, method validation, method design, and method transfer of laboratory procedures.
  • Ensure Quality Control decisions align with GMP, Quality System and regulatory requirements.
  • Responsible for release of raw materials, drug product, drug substance lots including approval of
  • Completed manufacturing batch records/QC data, review of nonconformances and ensuring investigation activities are being performed
  • Build, mentor, train, and manage a QC group
The QC Director will have the minimum requirements:
  • Bachelor’s Degree within the Life Sciences space
  • Quality Control focused on Gene Therapy is a MUST
  • Prior management of CMO/CRO relationships
  • Experience in vector design/production (lentiviral & AAV), retrovirology, writing SOPs, designing analyzing research data, cell line production, and validation protocols 
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