Senior Process Scientist - Lnp Process Development

Chiesi; Firenze; In loco; EUR 90.000 - 120.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Relocation support

Descrizione del lavoro

Chiesi Global Rare Diseases is seeking a Senior Process Scientist to drive formulation development, screening, and process optimization for LNP-based gene therapy programs. You will oversee external CROs/CDMOs and internal CMC teams to advance candidates from discovery through clinical development toward launch.

You will shape transfer strategies, ensure GMP manufacturing readiness, manage budgets, review technical documents, and contribute to regulatory sections.

Competenze

• MSc in a relevant field.
• 5–10 years of biotech/pharma experience.
• Exposure to gene editing, CGT/ATMPs and LNP delivery systems.
• GMP/regulatory knowledge and CMC development lifecycle.

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.

Conoscenze

Formulation development

Process development

Tech transfer

CRO/CDMO management

Regulatory documentation

Budget management

Cross-functional collaboration

DoE

CPP/CQA

Formazione

MSc in a relevant field

Descrizione del lavoro

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.

• pension
• private medical insurance
• relocation support
• 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
• MSc 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