CMC Associate, ATMP Manufacturing & Regulatory Support

Telethon; Milano; On-site; EUR 35,000 - 50,000; Full time

Job summary

Fondazione Telethon ets is seeking a CMC Associate to support Head of CMC and CMC Managers in cell and gene therapy programs. You will help manage stability, regulatory literature, and technology transfer within GMP frameworks.

Responsibilities include data handling, documentation, and collaboration across QA, Regulatory Affairs, and Manufacturing, ensuring patient safety and compliance in ATMP development.

Qualifications

• Bachelor's degree in a life science, biotechnology, biochemistry, pharmaceutical science, chemical or biochemical engineering, or related discipline.
• Master's degree in ATMPs, cell and gene therapy, or pharmaceutical Manufacturing/Quality is a plus.

Responsibilities

• Maintain CMC documentation systems with traceability and version control.
• Develop and maintain databases supporting stability programs, manufacturing data, and project deliverables.
• Track stability study schedules and results for vectors, plasmids, and drug products.
• Monitor CPPs, IPCs, and CQAs to support process understanding and improvement.
• Support data analysis and interpretation of process, analytical, and stability data.
• Contribute to investigations, root cause analyses, and CAPA processes.
• Prepare technical documentation, regulatory responses, and tech transfer activities.

Skills

Regulatory awareness

Data handling

Technical writing

Organisation

Judgement

English proficiency

Education

BSc in life science/biotech/pharma

Master's degree (ATMPs or related)

Tools

Excel

Statistical software

Electronic quality systems

Job description

Fondazione Telethon ets is seeking a CMC Associate to support Head of CMC and CMC Managers in cell and gene therapy programs. You will help manage stability, regulatory literature, and technology transfer within GMP frameworks.

Responsibilities include data handling, documentation, and collaboration across QA, Regulatory Affairs, and Manufacturing, ensuring patient safety and compliance in ATMP development.