Senior Process Scientist - gRNA process development

Chiesi Group; Brussel; On-site; EUR 90,000 - 130,000; Full time

Job summary

Chiesi Global Rare Diseases seeks a Senior Process Scientist to lead development and manufacturing of RNA-based gene editing components. You will guide process development, oversee gRNA workstreams, and manage outsourced activities with CROs/CDMOs, driving governance and risk management across GRD projects.

You will contribute to advancing gene therapy programs from candidate selection through development, supporting lifecycle management and clinical progression.

Qualifications

• Lead development plan for process development, manufacturing and controls for synthetic nucleotide projects.
• Develop and oversee gRNA development workstreams for technology transfers.
• Oversee outsourced process development activities; screen, select and onboard CROs/CDMOs; assist in auditing and qualification.
• Provide strong technical governance and oversight of external partners for robust execution.
• Proactive troubleshooting and risk management.
• Lead root cause investigations and deviation assessments.
• Review technical plans and batch documentation for GRD programs.

Responsibilities

• Define and lead the development plan for process development, manufacturing and controls strategy for synthetic nucleotide, acting as a SME for assigned projects.
• Design and oversee the gRNA development workstreams supporting technology transfers of manufacturing processes.
• Lead outsourced process development activities, including CRO/CDMO screening, selection and onboarding; support auditing and qualification.
• Provide strong technical governance and oversight of external partners, ensuring robust, scientifically sound execution.
• Proactive troubleshooting and risk management.
• Lead root cause investigations and deviation assessments.
• Reviewing technical plans, batch records, and related manufacturing documentation.

Skills

Process development

Manufacturing oversight

RNA-based gene editing

gRNA development

CRO/CDMO management

Technical governance

Root cause analysis

Risk management

Job description

Chiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.

At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.

Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.

Chiesi Global Rare Diseases

Chiesi Global Rare Diseases is a Chiesi Group's business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available.

This unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma.

Rare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. Discover more here.

What we are looking for

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