15 set - Parma
Chiesi
Overview
In this Senior Process Scientist role, you will lead process development and manufacturing oversight for gene therapy programs within Chiesi Global Rare Diseases, focusing on synthetic nucleotides and RNA-guided editing components. You will serve as SME on development plans, drive technology transfer, and support lifecycle management from candidate selection through clinical development toward launch. You will manage external partners and ensure robust, compliant execution within a cross-functional CMC team. This role offers impact on in vivo LNP programs, regulatory readiness, and a pathway to commercial readiness in a mission-driven, rare-disease context.
Retribuzione / Benefits
- pension
- private medical insurance
- wellbeing programme
- flexible benefits programme
- relocation support
- remote work options
Responsabilità
- Define and lead development plans for process development, manufacturing and controls strategy for synthetic nucleotides; act as SME for assigned projects.
- Design and oversee gRNA development workstreams supporting manufacturing technology transfers.
- Lead outsourced process development activities (CROs/CDMOs): screening, onboarding, auditing and qualification.
- Provide technical governance to external partners to ensure rigorous execution and continuous improvement.
- Proactively troubleshoot, manage risks, lead root-cause investigations and deviation assessments.
- Review technical plans, batch records, SOPs, and CDMO-generated reports.
- Manage budgets for process development (CROs/CDMOs/consultants).
- Contribute to project advancement as part of the CMC team, aligning with development, budget and regulatory strategy.
- Write, review and approve technical documentation (development protocols, reports, stability studies); contribute to IND/IMPD/IB sections.
- Support evaluation of external business development opportunities focused on oligonucleotide process development and control.
- Participate in continuous improvement an
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