27 set - Firenze
Chiesi
OverviewLa preghiamo di leggere attentamente la seguente descrizione del lavoro per assicurarsi di essere la persona giusta per questo ruolo prima di candidarsi.As Senior Process Scientist, you will drive the development and manufacturing oversight of LNP-based gene therapy programs within Chiesi Global Rare Diseases. You'll lead formulation development, screening, and process optimization, partnering with external CROs/CDMOs and internal CMC teams to advance candidates from discovery through clinical development toward launch. You will shape transfer strategies, ensure quality and regulatory readiness, and guide lifecycle improvements. This role offers impact across programs and a chance to shape GT delivery platforms in a collaborative, matrix-driven environment.Retribuzione / Benefitsannual premio schemepensionprivate medical insurancewellbeing programmeflexible benefitsrelocation supportResponsabilitàDefine and lead formulation development plans for LNP platforms, including lipid/excipient screening and process developmentOversee external manufacturing activities and tech transfers; select and qualify CROs/CDMOsProvide technical governance for outsourced work; troubleshoot and drive continuous improvementReview technical documents (batch records, SOPs, reports) and contribute to regulatory sections (IND, IMPD,
IB)Manage project budgets for CROs/CDMOs/consultants and support lifecycle managementContribute to GRD/GRD R&D strategy and cross-functional knowledge sharingLead root cause investigations and deviation assessmentsSupport critical evaluation of external business development opportunities focused on oligonucleotidesRequisiti fondamentaliMSc in a relevant field5-10 years of biotech/pharma experience with exposure to gene editing, CGT/ATMPs and LNP delivery systemsStrong expertise in formulation screening/optimization, process development, scale-up, and tech transfer to GMP manufacturingQbD-based development (DoE, xysqume CPP/CQA identification) and understanding of CQAsExperience managing outsourced development (CROs/CDMOs) and technical documentationGMP/regulatory knowledge and CMC development lifecycle; ability to operate in amatrix organizationExcellent analytical, writing, and stakeholder management skillsstrong communication and stakeholder management in an international environmentproblem-solving mindset with hands-on, pragmatic approachability to influence cross-functional teamsLNP formulation development and screeningProcess development and scale-upTech transfer to GMP manufacturing
28 set - Brignano Superiore
IT.COR
28 set - Lecco
Tradergy
28 set - Genova
IT.COR
28 set - Sassari
Tradergy