CMC Associate

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/89wnoh

Fondazione 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.

The CMC function is what turns those therapies into products that can be manufactured reproducibly, released reliably and defended to a Regulator.
This role sits at the point where laboratory science becomes a medicine.
Supporting 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.

RESPONSIBILITIES:

The CMC Associate provides hands-on technical and documentation support to the Head of CMC and CMC Managers across assigned cell and gene therapy programs.

The role has three purposes:

• To deliver defined CMC work packages under supervision;
• As part of the CMC team, respond to Manufacturing technical and Quality needs to ensure patient safety, Manufacturing best practice and Regulatory compliance;
• Help build Fondazione Telethon technical breadth, Regulatory literacy and judgement required to improve CMC capability and progress programs to patient treatment.

Key Responsibilities

• Maintain CMC documentation systems, ensuring traceability, version control, and proper document management across internal teams and external partners.
• Develop and maintain databases to support CMC activities, including stability programs, manufacturing data, a

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/89wnoh