17 set - Pistoia
Chiesi
Overview La preghiamo di leggere attentamente la seguente descrizione del lavoro per assicurarsi di essere la persona giusta per questo ruolo prima di candidarsi.
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 premio 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
- QbD-based development (DoE, xkiyazw 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
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