Senior Process Scientist - LNP process development; Europe, remote, IT

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 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.

This is what you will do Chiesi Global Rare disease is recruiting a Senior Process scientist with deep expertise in the development and production of lipid nanoparticle (LNP) formulations for nucleic acid delivery. In this role, you will be a key member of the CMC Extended Technical Team (ETT) supporting the CMC Technical leader while being responsible for process development and manufacturing oversight of gene therapy (GT) programs across GRD projects.

You will contribute to advancing in vivo LNP programs 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 formulation development and lipids and exipient screening, process development, manufacturing and controls strategy for LNP platforms, acting as a subject matter expert (SME) for the assigned projects.

Design and oversee the LNP development workstream supporting technology transfers of manufacturing processes and acting as the lead for outsourced process development activities, including:
Screening, selection and onboarding of suitable CROs/CDMOs; support in auditing and qualification Providing strong technical governance and oversight, Technical oversight and governance of external partners, ensuring robust and scientifically sound execution execution of external activities while driving accountability and continuous improvement. Proactive troubleshooting and risk management Lead root cause investigations and deviation assessments Reviewing technical plans, batch records, SOP and reports review generated at the CDMO Managing process development project budgets (CROs, CDMOs, consultants).

Actively contribute to project advancement as a key member of the CMC team, supporting the CMC lead and ensuring alignment with overall development, budget and regulatory strategy. Write, review, and approve technical documentation within the…