22 set - Modena
Evotec Group
Overview As QC Manager for ATMP, you ensure compliant, timely QC testing for GMP manufacturing of patient-specific therapies. You will lead the QC lab, oversee method qualification and transfer, and manage external and internal stakeholders to support batch release and regulatory readiness. You will drive GMP compliance, CAPAs, deviations, and change controls while developing a high-performing QC team. This role offers impact in advancing innovative cell and gene therapies at Evotec.
Responsabilità
- Manage day-to-day QC lab operations across raw materials, in-process, and final product testing
- Lead analytical method qualification, validation, and transfer
- Oversee analytical methods including flow cytometry, qPCR/ddPCR, and cell-based assays
- Ensure timely execution and review of testing to support batch release
- Manage external contract workers and outsourced QC testing within planned timeframes
- Author, review and approve technical reports and QC documentation
- QC data collection and analysis
- Ensure GMP compliance including deviations, OOS/OOT, CAPAs, and change control
- Lead and develop QC team members
- Oversee laboratory equipment qualification and environmental monitoring
- Support regulatory inspections and filings
- Provide support to perform internal audits
- Represent QC team at technical meetings presenting and discussing results
- Promote and maintain a high level of GMP awareness and compliance
Requisiti fondamentali
- Degree in Biology, Biotechnology, Pharmacy, or related field; PhD preferred
- 5+ years of QC experience in ATMP (cell therapy and gene therapy preferred)
- Relevant previous experience as QC manager
- Solid expertise in cytofluorimetry (data acquisition and analysis)
- Strong expertise in biochemistry, microbiological, molecular biology and cell culture methods
- Ability to analyze data, summarize results, and identify solutions
- Excellent knowledge of current GxP guideline and ATMP regulations
- Strong leadership and communi
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