pFondazione Telethon ETS (FT) is committed to developing therapeutic options for patients affected by rare genetic disorders. FT pipeline consists in various programs at different development stages (from pre-clinical to commercial). For such programs, Telethon is responsible, among others, to act as Sponsor in the conduction of clinical trials to assess safety and efficacy of Advanced Therapy Medicinal Products and as Marketing Authorization Holder in guaranteeing post-marketing pharmacovigilance. /ppThe CMC function is what turns those therapies into products that can be manufactured reproducibly, released reliably and defended to a Regulator. /ppThis role sits at the point where laboratory science becomes a medicine. /ppSupporting Chemistry, Manufacturing and Controls (CMC) activities for Advanced Therapy Medicinal Products (ATMPs), including gene and cell therapy programs focused on rare and pediatric diseases. Working under the guidance of the CMC manager, the role provides exposure to CMC development, GMP manufacturing oversight, stability management, regulatory support, and technology transfer activities. /ppbRESPONSIBILITIES: /b /ppThe CMC Associate provides hands-on technical and documentation support to the Head of CMC and CMC Managers across assigned cell and gene therapy programs. /ppThe role has three purposes: /pulliTo deliver defined CMC work packages under supervision; /liliAs part of the CMC team, respond to Manufacturing technical and Quality needs to ensure patient safety, Manufacturing best practice and Regulatory compliance; /liliHelp build Fondazione Telethon technical breadth, Regulatory literacy and judgement required to improve CMC capability and progress programs to patient treatment. /li /ulpKey Responsibilities /ppMaintain CMC documentation systems, ensuring traceability, version control, and proper document management across internal teams and external partners. /ppDevelop and maintain databases to support CMC activities, including stability programs,



manufacturing data, and project deliverables. /ppTrack stability study schedules and results for WCBs, plasmids, lentiviral vectors (LVVs), drug products (DPs), critical raw materials, and analytical cell lines. /ppSupport trend analysis of stability, manufacturing, and analytical data, escalating out-of-trend results and potential risks. /ppMonitor Critical Process Parameters (CPPs), In-Process Controls (IPCs), and Critical Quality Attributes (CQAs) to support process understanding and continuous improvement. /ppPerform data analysis and support interpretation of process, analytical, and stability data. /ppContribute to investigations, root cause analyses, and continuous improvement initiatives. /ppSupport preparation of technical documentation, regulatory responses, and technology transfer activities. /ppCollaborate with Process Development, Manufacturing, Quality Assurance, Regulatory Affairs, Supply Chain, and external CDMOs to ensure alignment on project objectives and timelines. /ppTake ownership of assigned activities, proactively identifying risks, gaps, and improvement opportunities, while escalating issues when appropriate. /ppbQUALIFICATIONS /b /ppbEducation /b /pulliBachelor's degree in a life science, biotechnology, biochemistry, pharmaceutical science, chemical or biochemical engineering, or a related technical discipline. /li /ulpNice to have: Master's degree in a relevant discipline, or postgraduate coursework covering ATMPs, cell and gene therapy, or pharmaceutical Manufacturing/Quality team experience. /ppbSkills and Knowledge /b /ppRegulatory awareness.



Working awareness of the EU and FDA regulatory framework for ATMPs, and of ICH Q8, Q9 and Q10 principles. Depth is not expected on entry; curiosity and the ability to read a guideline and apply it are. /ppData handling. Competent Excel — trending, pivot tables, charting, handling large datasets without loss of integrity. Familiarity with statistical software or electronic quality systems is an advantage. /ppTechnical writing. Ability to write clear, precise, defensible technical English suitable for a regulatory audience. /ppOrganisation. Rigour in tracking many parallel deliverables across multiple programs, with accurate status reporting and no dropped actions. /ppJudgement. The instinct to elevate early. In this role, a question asked too soon costs nothing; a question asked too late costs a batch. /ppLanguage. Professional working proficiency in English is essential — it is the working language of the team and of all regulatory documentation. Italian is the native Fondazione Telethon language and fluency is highly desirable for most effective execution of the role. /ppbExperience /b /ppOne to three years' experience in a GMP-regulated biotechnology or pharmaceutical environment. Preferred functional backgrounds: quality control (analytical testing and method work); GMP manufacturing or MSAT; process development. /ppDemonstrable hands-on laboratory or manufacturing-floor experience within a formal quality system. /ppPractical exposure to controlled documentation — batch records, protocols, test methods, logbooks. /ppNice to have /ppCell and gene therapy, viral vector, or wider biologics experience. /ppInvolvement in a stability programme, or in deviation and CAPA processes. /ppExposure to technology transfer between sites or to a CDMO. /ppAny exposure to IMPD, IND or CTD Module 3 content. /ppbOther Informations /b /ppSalary Range: 35.000 - 50.000€ /p #J-18808-Ljbffr

📌 CMC Associate (Milano)
🏢 Telethon
📍 Milano