Senior gRNA Process Scientist — Remote/Hybrid

Biopharma Careers; Parma; Ibrido; EUR 53.000 - 65.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Wellbeing programme

Descrizione del lavoro

Chiesi Global Rare Diseases seeks a Senior Process Scientist to lead development and manufacturing oversight for gene-editing programs across GRD projects. You will support in vivo LNP programs from candidate selection through clinical development, contributing to lifecycle management and regulatory strategy.

You will coordinate outsourced activities, review technical documentation, and ensure robust governance with CROs/CDMOs while collaborating with the CMC team to drive development timelines

Competenze

• Minimum MSc in a relevant field (biotechnology, bioengineering, biology, biochemistry, chemistry, chemical engineering or a related field)
• 5-10 years of relevant industrial experience in biotech/pharma with significant exposure to gene editing, CGT/ATMPs and nucleic acid-based products development
• Strong expertise in: Process development, scale-up, technology transfer to GMP manufacturing, and process validation for gRNA-based products
• QbD-based development (DoE, CPP/CQA identification) and manufacturing
• Control strategy development and risk assessment for complex biologics
• Proven experience managing outsourced development activities (CROs/CDMOs), including technical oversight, troubleshooting and escalation management
• Solid understanding of GMP, regulatory requirements, and CMC development lifecycle
• Demonstrated ability to operate in a matrix organization and influence cross-functional teams
• Strong skills in technical writing, data review, and regulatory documentation
• Excellent problem-solving mindset with a hands-on, pragmatic, and results-driven approach

Mansioni

• Define and lead the development plan for process development, manufacturing and controls strategy for synthetic nucleotide, acting as a SME for the assigned projects.
• Design and oversee the gRNA development workstreams supporting technology transfers of manufacturing processes
• Acting as the lead for outsourced process development activities, including: screening, selection and onboarding of CROs/CDMOs; support in auditing and qualification
• Providing strong technical governance and oversight of external partners, ensuring robust and scientifically sound execution of external activities while driving accountability and continuous improvement
• Proactive troubleshooting and risk management
• Lead root cause investigations and deviation assessments
• Reviewing technical plans, batch records, SOPs and reports generated at the CDMO
• Managing process development project budgets (CROs, CDMOs, consultants)
• Actively contribute to project advancement as a key member of the CMC team, supporting the CMC lead and ensuring alignment with development, budget and regulatory strategy
• Write, review, and approve technical documentation within the area of responsibility, including development protocols and reports, stability studies, and contributing to regulatory sections (IND, IMPD, IB)
• Support the critical evaluation of external business development opportunities, focusing on process development and control for oligonucleotides
• Participate in continuous improvement and lifecycle management activities
• Contribute to development of the department in line with GRD and GRD R&D goals, sharing knowledge and best practices

Conoscenze

Process development

GMP knowledge

Regulatory documentation

DoE

Risk assessment

CDMO oversight

Technical writing

gRNA development

CMC lifecycle

GMP manufacturing

Formazione

MSc in biotechnology

Descrizione del lavoro

Chiesi Global Rare Diseases seeks a Senior Process Scientist to lead development and manufacturing oversight for gene-editing programs across GRD projects. You will support in vivo LNP programs from candidate selection through clinical development, contributing to lifecycle management and regulatory strategy.

You will coordinate outsourced activities, review technical documentation, and ensure robust governance with CROs/CDMOs while collaborating with the CMC team to drive development timelines