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Quality Control Manager in Advanced Therapy Medicinal Product
Evotec —Modena, Emilia-Romagna
- Tempo pieno
- Dottorato di ricerca
- Inglese
- Microsoft Office
11 giorni

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Quality Control Manager in Advanced Therapy Medicinal Product

Evotec -
Modena, Emilia-Romagna

Candidati adesso

Dettagli della posizione

Tempo pieno
11 giorni fa

Qualifiche

Biologia
Dottorato di ricerca
Inglese
Microsoft Office
Controllo qualità
Farmacia
Leadership

Descrizione completa della posizione

Position Summary:

We are seeking an experienced Quality Control (QC) Manager – ATMP to lead QC laboratory operations supporting GMP manufacturing of advanced therapy medicinal products. This role is critical in ensuring timely and compliant release of patient-specific therapies and maintaining the highest standards of quality and regulatory compliance.

Key Responsibilities:

Manage day-to-day QC lab operations, including 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, ensuring outsourced QC testing operations are performed as required and within the planned timeframe
Author, review and approve technical reports and QC documentation
QC data collection and analysis
Ensure GMP compliance, including handling 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

Qualifications and experience:

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

Required Skills & Abilities:

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 communication skills
Positive, team player and problem-solving attitude
Accurate, with excellent prioritization and organization skills
Commitment to the assigned deadlines and ability to deliver them tightly
Good knowledge of Microsoft Office applications
English intermediate level is required (written and spoken)
Good verbal, written, and interpersonal communication skills
Ability to work independently, maintaining a team-focused attitude
Open-minded and problem-solving attitude.

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.

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Quality Control Manager in Advanced Therapy Medicinal Product

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