Senior Process Scientist - LNP process development

Overview

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.

Retribuzione / Benefits

annual bonus scheme

pension

private medical insurance

wellbeing programme

flexible benefits

relocation support

Responsabilità

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

Requisiti fondamentali

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

Qb

D-based development (Do

E, 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