Senior Analytical Scientist - Bioassay CGT/ATMP (Europe, remote, IT)

About us

Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.

At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.

Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.
Chiesi Global Rare Diseases

Chiesi Global Rare Diseases is a Chiesi Group ’s business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available.

This unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma.

Rare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. Discover more here.
What we are looking for

This is what you will do

Chiesi Global Rare disease is recruiting for a Senior Analytical Scientist with deep expertise in development of complex analytical methods including bioassays and cell-based potency assays for the characterization of ATMP including oligonucleotides, lipid nanoparticle (LNP) based products and other modalities.

In this role, you will be a key member of the CMC Extended Technical Team (ETT) , operating in a matrix organisation and responsible for driving analytical development and control strategy for gene editing products within the GRD function from candidate selection though clinical development and toward commercial launch, while also supporting lifecycle management activities.

You will be responsible for

- Define and lead the development plan for bioanalytical and potency assay strategies for gene editing and nucleic acid-based therapeutics, acting as a subject matter expert (SME) in method development, validations and control strategies for the assigned projects

- Drive fit-for-purpose assay development, evolving from early development to late-stage/GMP

- Design and oversee the development of cell-based potency assays (primary cells, immortalized lines, reporter systems), functional assays for gene editing efficiency (e.g., knockout/knock-in models), mechanism-based assays reflecting biological activity (e.g., transfection, expression, editing efficiency)

- Implement and oversee assay qualification/validation (accuracy, precision, specificity, linearity, robustness), stability-indicating and comparability assays,

- Contribute to analytical characterization packages, linking potency to CQAs

- Act as primary analytical lead for outsourced activities, including:
- Selection and onboarding of CROs/CDMOs, including support in auditing and qualification

- Technical oversight and governance of external partners ensuring robust and scientifically sound follow-up of external activities, driving accountability and continuous improvement.

- Proactive troubleshooting and risk management

- Review of critical protocol, methods and data generated at the CDMO

- Manage analytical project budgets (CROs, CDMOs, consultants).

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