14 set - Macerata
Chiesi
OverviewAs 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 scheme
pension
private medical insurance
wellbeing programme
flexible benefits
relocation support
ResponsabilitàDefine and lead formulation development plans for LNP platforms, including lipid/excipient screening and process development
Oversee external manufacturing activities and tech transfers; select and qualify CROs/CDMOs
Provide technical governance for outsourced work; troubleshoot and drive continuous improvement
Review technical documents (batch records, SOPs, reports) and contribute to regulatory sections (IND, IMPD, IB)
Manage project budgets for CROs/CDMOs/consultants and support lifecycle management
Contribute to GRD/GRD R&D; strategy and cross-functional knowledge sharing
Lead root cause investigations and deviation assessments
Support critical evaluation of external business development opportunities focused on oligonucleotides
Requisiti fondamentaliMSc in a relevant field
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; ability to operate in a matrix organization
Excellent analytical, writing, and stakeholder management skills
strong communication and stakeholder management in an international environment
problem-solving mindset with hands-on, pragmatic approach
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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