Senior LNP Process Scientist: Gene Therapy & Tech Transfer

Chiesi; Ferrara; In loco; EUR 70.000 - 110.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Relocation support

Descrizione del lavoro

Chiesi is seeking a Senior Process Scientist to drive formulation development and manufacturing oversight of LNP-based gene therapy programs. You will lead screening, process development, scale-up, and tech transfer to GMP manufacturing, partnering with CROs/CDMOs and internal CMC teams.

You will shape strategy, QA/regulatory readiness, and lifecycle improvements, review technical documents, manage budgets, and guide cross-functional teams in a matrix environment to advance candidates toward

Competenze

• MSc in a relevant field and 5–10 years of biotech/pharma experience.
• Experience with gene editing, CGT/ATMPs and LNP delivery systems.
• Strong formulation screening, process development, scale-up and tech transfer to GMP.

Mansioni

• Define 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
• LNP formulation development and screening
• Process development and scale-up
• Tech transfer to GMP manufacturing

Conoscenze

LNP formulation

Formulation screening

Process development

Tech transfer

DoE

CPP/CQA

GMP experience

Regulatory knowledge

Cross-functional

Stakeholder mgmt

Formazione

MSc in a relevant field

Descrizione del lavoro

Chiesi is seeking a Senior Process Scientist to drive formulation development and manufacturing oversight of LNP-based gene therapy programs. You will lead screening, process development, scale-up, and tech transfer to GMP manufacturing, partnering with CROs/CDMOs and internal CMC teams.

You will shape strategy, QA/regulatory readiness, and lifecycle improvements, review technical documents, manage budgets, and guide cross-functional teams in a matrix environment to advance candidates toward