22 set - Terni
Chiesi
Overview 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. This role offers impact across programs and a chance to shape GT delivery platforms in a collaborative, matrix-driven environment.
Retribuzione / Benefits annual premio scheme pension private medical insurance flexible benefits relocation support Define and lead formulation development plans for LNP platforms,
including lipid/excipient screening and process development select and qualify CROs/CDMOs Manage project budgets for CROs/CDMOs/consultants and support lifecycle management Contribute to GRD/GRD R&D; strategy and cross-functional knowledge sharing Support critical evaluation of external business development opportunities focused on oligonucleotides 5-10 years of biotech/pharma experience with exposure to gene editing, CGT/ATMPs and LNP delivery systems ~ Strong expertise in formulation screening/optimization, process development, scale-up, and tech transfer to GMP manufacturing ~ QbD-based development (DoE, CPP/CQA identification) and understanding of CQAs ~ Experience managing outsourced development (CROs/CDMOs) and technical documentation ~ GMP/regulatory knowledge and CMC development lifecycle; Excellent analytical, writing, and stakeholder management skills ~ strong communication and stakeholder management in an international environment ~ ability to influence cross-functional teams ~ LNP formulation development and screening ~ Process development and scale-up ~ Tech transfer to GMP manufacturing
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Snai
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Serafina
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Il Globo Vigilanza
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Kpmg Italy