Senior Process Scientist - gRNA process development

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.
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.
Senior Process Scientist – gRNA process development
Business Area: R&D, Pharmacovigilance & Regulatory Affairs
Job Type: Direct Employee
Contract Type:
Permanent

Location:

Parma, IT (this position can be based anywhere in Europe with hybrid and remote options)
What you will do
Senior Process scientist with deep expertise in the development and production of critical RNA-based gene editing components.

Key responsibilities include:

Define and lead the development plan for process development, manufacturing and controls strategy for synthetic nucleotide, acting as a subject matter expert for assigned projects.
Design and oversee the gRNA development work streams supporting technology transfers of manufacturing processes.
Lead outsourced process development activities, including screening, selection and onboarding of suitable CROs/CDMOs, support in auditing and qualification.
Provide 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.
Review technical plans, batch records, SOPs and reports generated at the CDMO.
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, reports, stability studies and contribute to relevant regulatory sections (IND, IMPD, IB).
Support critical evaluation of external business development opportunities, focusing on process development and control for oligonucleotides.
Participate in continuous improvement and life cycle management activities.
Contribute 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.

Qualifications

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, chemo‑enzymatic 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.
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…