Quality Control Manager in Advanced Therapy Medicinal Product

Evotec WD; Modena; In loco; EUR 55.000 - 75.000; Tempo pieno

Descrizione del lavoro

Evotec WD is seeking an experienced Quality Control Manager - ATMP in Modena, Italy. This role leads QC laboratory operations to support GMP manufacturing of advanced therapy medicinal products, ensuring compliance with regulatory standards and timely release of therapies.

The ideal candidate has a degree in Biology, Biotechnology, or related field, plus over 5 years of relevant QC experience. The position requires strong leadership and communication skills.

Competenze

• 5+ years of QC experience in ATMP (cell therapy and gene therapy preferred).
• Solid expertise in cytofluorimetry including data acquisition and analysis.
• Excellent knowledge of current GxP guidelines and ATMP regulations.

Mansioni

• Manage day-to-day QC lab operations, including raw materials, in-process, and final product testing.
• Lead analytical method qualification, validation, and transfer.
• Ensure timely execution and review of testing to support batch release.

Conoscenze

Cytofluorimetry expertise

Biochemistry knowledge

Microbiological methods

Molecular biology techniques

Cell culture methods

Data analysis skills

Leadership skills

Communication skills

Problem-solving attitude

Microsoft Office proficiency

Formazione

Degree in Biology, Biotechnology, Pharmacy or related field

PhD preferred

Descrizione del lavoro

## Quality Control Manager in Advanced Therapy Medicinal ProductApplylocations: Modenatime type: Full timeposted on: Posted 2 Days Agojob requisition id: JOB ID-14398**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.### About UsEvotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company’s multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec leverages this “Data-driven R&D Autobahn to Cures” for proprietary projects and within a network of partners including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 5,000 highly qualified people. The Company’s 17 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to www.evotec.com and follow us on X/Twitter @Evotec and LinkedIn.