Senior Process Scientist - gRNA process development

This is what you will do

Chiesi Global Rare disease is recruiting a Senior Process scientist with deep expertise in the development and production of critical RNA-based gene editing components.

In this role, you will be a key member of the CMC Extended Technical Team (ETT) supporting the CMC Technical leader while being responsible for process development and manufacturing oversight of gene therapy (GT) programs across GRD projects. You will  contribute to advancing in vivo LNP programs from candidate selection though clinical development and toward commercial launch, while also supporting lifecycle management activities.

You will be responsible for

• Define and lead the development plan for process development, manufacturing and controls strategy for synthetic nucleotide, acting as a subject matter expert (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 suitable 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, SOP 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 overall development, budget and regulatory strategy.
• Write, review, and approve technical documentation within the area of responsibility, including development protocols and reports, stability studies ,  and contribute to relevant 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 life cycle management activities.
• Actively contributing to the development of the department in line with GRD and GRD R&D strategic goals, sharing knowledge, and best practices within department and to relevant adjacent functions at Chiesi.

You will need to have

• 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 the biotech/pharmaceutical industry 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 (critical requirement)
  • Synthetic nucleotide manufacturing modalities (solid-phase oligo synthesis, enzymatic synthesis, chemoenzymatic ligation) and their linkage with CQAs
  • 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
  • Critical and data-driven performance monitoring
• Solid understanding of GMP, regulatory requirements, and CMC development lifecycle.
• Demonstrated ability to operate effectively 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.
• Strong communication and stakeholder management skills in an international environment.

Location

This position can be based anywhere in Europe, with both hybrid and remote work options.

Compensation range

The package outlined below is based on the role being located in Italy. Where the role is offered in a different country, the applicable salary, bonus and benefits will be aligned to the relevant local market and internal frameworks. Full details of the applicable package will be provided at the appropriate stage of the recruitment process.