Quality Control Manager in Advanced Therapy Medicinal Product

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7bbkrp

ph3Position Summary /h3 pWe 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. /p h3Key Responsibilities /h3 ul liManage day‑to‑day QC lab operations, including raw materials, in‑process, and final product testing. /li liLead analytical method qualification, validation, and transfer. /li liOversee analytical methods including flow cytometry, qPCR/ddPCR, and cell‑based assays. /li liEnsure timely execution and review of testing to support batch release. /li liManage external contract workers, ensuring outsourced QC testing operations are performed as required and within the planned timeframe. /li liAuthor, review and approve technical reports and QC documentation. /li liQC data collection and analysis. /li liEnsure GMP compliance, including handling deviations, OOS/OOT, CAPAs, and change control. /li liLead and develop QC team members. /li liOversee laboratory equipment qualification and environmental monitoring. /li liSupport regulatory inspections and filings. /li liProvide support to perform internal audits. /liliRepresent QC team at technical meetings presenting and discussing results. /li liPromote and maintain a high level of GMP awareness and compliance.



/li /ul h3Qualifications And Experience /h3 ul liDegree in Biology, Biotechnology, Pharmacy, or related field; PhD preferred. /li li5+ years of QC experience in ATMP (cell therapy and gene therapy preferred). /li liRelevant previous experience as QC manager. /li /ul h3Required Skills Abilities /h3 ul liSolid expertise in cytofluorimetry (data acquisition and analysis). /li liStrong expertise in biochemistry, microbiological, molecular biology and cell culture methods. /li liAbility to analyze data, summarize results, and identify solutions. /li liExcellent knowledge of current GxP guideline and ATMP regulations. /li liStrong leadership and communication skills. /li liPositive, team player and problem‑solving attitude. /li liAccurate, with excellent prioritization and organization skills. /li liCommitment to the assigned deadlines and ability to deliver them tightly. /li liGood knowledge of Microsoft Office applications. /li liEnglish intermediate level required (written and spoken). /li liGood verbal, written, and interpersonal communication skills. /li liAbility to work independently, maintaining a team‑focused attitude. /li liOpen‑minded and problem‑solving attitude. /li /ul pIn the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities. /p /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7bbkrp