About usChiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. Si candidi rapidamente per massimizzare le sue possibilità di essere considerato/a per un colloquio. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. As a Vantaggi Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.We believe our differences make us stronger. Chiesi Global Rare DiseasesChiesi 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. What we are looking forThis is what you will doChiesi Global Rare disease is recruiting a Senior Process scientist with deep expertise in the development and production of critical RNA-based gene editing components.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 forDefine and lead the development plan for process development,



manufacturing and controls strategy for synthetic nucleotide, acting as a subject matter expert (SME) for the assigned projects.Design and oversee the gRNA development workstreams supporting technology transfers of manufacturing processes Acting as the lead for outsourced process development activities, including:Screening, selection and onboarding of suitable CROs/CDMOs; support in auditing andqualificationProviding strong technical governance and oversight, of external partners, ensuring robust and scientifically sound execution of external activities while driving accountability and continuous improvement.Proactive troubleshooting and risk management Lead root cause investigations and deviation assessmentsReviewing technical plans, batch records, SOP and reports generated at the CDMOManaging 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 area of responsibility, including development protocols and reports, stability studies, and contribute to relevant regulatory sections (IND, IMPD, IB)Support the critical evaluation of external business development opportunities, focusing on process development and control for oligonucleotides.Participate in continuous improvement and life cycle management activities.Actively contributing to the development of the department in line with GRD and GRD R&D; strategic goals, sharing knowledge, and best practices within department and to relevant adjacent functions at Chiesi.You will need to haveMinimum MSc in a relevant field (biotechnology, bioengineering, biology, biochemistry, chemistry, chemical engineering or a related field)5-10 years of relevant industrial experience in the biotech/pharmaceutical industry with significant exposure to gene editing, CGT/ATMPs and nucleic acid-based products developmentStrong expertise in:Process development, scale-up, technology

📌 Senior Process Scientist - Grna Process Development (Emilia-Romagna)
🏢 Cv-Library
📍 Emilia-Romagna