CMC Associate

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 (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, and project deliverables.

Track stability study schedules and results for WCBs, plasmids, lentiviral vectors (LVVs), drug products (DPs), critical raw materials, and analytical cell lines.

Support trend analysis of stability, manufacturing, and analytical data, escalating out-of-trend results and potential risks.

Monitor Critical Process Parameters (CPPs), In-Process Controls (IPCs), and Critical Quality Attributes (CQAs) to support process understanding and continuous improvement.

Perform data analysis and support interpretation of process, analytical, and stability data.

Contribute to investigations, root cause analyses, and continuous improvement initiatives.

Support preparation of technical documentation, regulatory responses, and technology transfer activities.

Collaborate with Process Development, Manufacturing, Quality Assurance, Regulatory Affairs, Supply Chain, and external CDMOs to ensure alignment on project objectives and timelines.

Take ownership of assigned activities, proactively identifying risks, gaps, and improvement opportunities, while escalating issues when appropriate.

QUALIFICATIONS

Education

• Bachelor's degree in a life science, biotechnology, biochemistry, pharmaceutical science, chemical or biochemical engineering, or a related technical discipline.

Nice to have: Master's degree in a relevant discipline, or postgraduate coursework covering ATMPs, cell and gene therapy, or pharmaceutical Manufacturing/Quality team experience.

Skills and Knowledge

Regulatory 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.

Data 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.

Technical writing. Ability to write clear, precise, defensible technical English suitable for a regulatory audience.

Organisation. Rigour in tracking many parallel deliverables across multiple programs, with accurate status reporting and no dropped actions.

Judgement. The instinct to elevate early. In this role, a question asked too soon costs nothing; a question asked too late costs a batch.

Language. 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.

Experience

One 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.

Demonstrable hands-on laboratory or manufacturing-floor experience within a formal quality system.

Practical exposure to controlled documentation — batch records, protocols, test methods, logbooks.

Nice to have

Cell and gene therapy, viral vector, or wider biologics experience.

Involvement in a stability programme, or in deviation and CAPA processes.

Exposure to technology transfer between sites or to a CDMO.

Any exposure to IMPD, IND or CTD Module 3 content.

Other Informations

Salary Range: 35.000 - 50.000€