Senior LNP Process Scientist: Formulation & Tech Transfer

Chiesi; Terni; In loco; EUR 90.000 - 130.000; 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 LNP formulation development and oversee scalable processes from discovery to GMP manufacturing. You will manage external CRO/CDMO partnerships, lead tech transfers, and ensure regulatory readiness across IND/IMPD/IB, while guiding lifecycle improvements in a matrix-driven environment.

The role requires 5–10 years in biotech/pharma with LNP, CGT/ATMP exposure, DoE/CQAs, and strong cross-functional collaboration across international teams.

Competenze

• MSc in a relevant field required.
• 5–10 years in biotech/pharma with CGT/ATMPs and LNP delivery exposure.
• Strong expertise in formulation screening, process development, scale-up, and tech transfer to GMP manufacturing.
• GMP/regulatory knowledge and CQAs awareness.
• Experience managing outsourced development and regulatory documents.
• Excellent analytical, writing, and stakeholder management skills.

Mansioni

• Define and lead formulation development plans for LNP platforms.
• Oversee external manufacturing activities and tech transfers; select CROs/CDMOs.
• Provide technical governance for outsourced work; drive continuous improvement.
• Review batch records, SOPs, and reports; contribute to IND/IMPD/IB sections.
• 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 business development opportunities focused on oligonucleotides.
• Lead LNP formulation development and screening.
• Process development and scale-up.
• Tech transfer to GMP manufacturing.

Conoscenze

LNP formulation

Process development

Tech transfer

DoE

CQAs

Outsourced mgmt

GMP/regulatory

Stakeholder mgmt

Budget mgmt

Documentation

Formazione

MSc in a relevant field

Descrizione del lavoro

Chiesi is seeking a Senior Process Scientist to drive LNP formulation development and oversee scalable processes from discovery to GMP manufacturing. You will manage external CRO/CDMO partnerships, lead tech transfers, and ensure regulatory readiness across IND/IMPD/IB, while guiding lifecycle improvements in a matrix-driven environment.

The role requires 5–10 years in biotech/pharma with LNP, CGT/ATMP exposure, DoE/CQAs, and strong cross-functional collaboration across international teams.