Senior Process Scientist - Lnp Process Development

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

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

Senior Process Scientist - LNP process development terni, umbria, it