14 set - Emilia-Romagna
Chiesi
OverviewIn 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 / Benefitspension
private medical insurance
wellbeing programme
flexible benefits programme
relocation support
remote work options
ResponsabilitàDefine 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 and lifecycle management; contribute to GRD and R&D; strategic goals.
Requisiti fondamentaliMSc in biotechnology, bioengineering, biology, biochemistry, chemistry, chemical engineering or related field
5–10 years of relevant industrial experience in biotech/pharma with exposure to gene editing, CGT/ATMPs and nucleic acid products development
Strong expertise in process development, scale-up, tech transfer to GMP manufacturing, and process validation for gRNA-based products
Knowledge of synthetic nucleotide manufacturing modalities and their link to CQAs
QbD-based development (DoE, CPP/CQA) and manufacturing
Control strategy development and risk assessment for complex biologics
Experience managing outsourced development activities (CROs/CDMOs) including technical oversight and performance monitoring
Solid understanding of GMP, regulatory requirements, and CMC lifecycle; ability to operate in a matrix organization
Strong technical writing, data review, and regulatory documentation skills
Excellent problem-solving, hands-on, results-driven mindset; strong communication and stakeholder management in an international environment
Strong communication
Stakeholder management
Team collaboration
Process development
Technology transfer to GMP
GNR/oligonucleotide manufacturing
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