Senior QC Microbiology Lead — Cell Therapy

legendcareers

Raritan (NJ)

On-site

USD 150,000 - 190,000

Full time

4 days ago
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Job summary

Legend Biotech is seeking a Sr. Manager, QC Microbiology in Raritan, NJ to lead QC microbiology labs supporting cell therapy manufacturing. You will hire, coach and evaluate staff, review data, and drive microbiology procedures and investigations in a fast‑paced environment.

You will guide method verification/validation, instrument qualification, and process verification, while partnering with QA, Manufacturing and Engineering to meet regulatory and business goals.

Qualifications

  • Bachelor's Degree in Science, Biology or equivalent.
  • 12–14 years in aseptic manufacturing or QC microbiology with leadership.
  • Experience with quality systems, regulatory guidance, and data analysis.

Responsibilities

  • Oversee operation and workflow of QC microbiology labs.
  • Hire, develop and manage staff; review lab data and investigations.
  • Lead validation/transfer activities, equipment qualification, and troubleshooting.
  • Manage budgets, staffing plans and cross‑functional collaboration.
  • Ensure compliance with cGMP, quality systems, and regulatory guidelines.

Skills

Leadership
Quality systems
Statistical analysis
cGMP know-how
Collaboration

Education

Bachelor's degree in Science/Biology

Job description

Legend Biotech is seeking a Sr. Manager, QC Microbiology in Raritan, NJ to lead QC microbiology labs supporting cell therapy manufacturing. You will hire, coach and evaluate staff, review data, and drive microbiology procedures and investigations in a fast‑paced environment.

You will guide method verification/validation, instrument qualification, and process verification, while partnering with QA, Manufacturing and Engineering to meet regulatory and business goals.

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