Job Description & How to Apply Below
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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 forThis 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 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 work streams 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 CDMOManaging 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 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 CQAsQbD-based development (DoE, CPP/CQA identification) and manufacturing
Control strategy development and risk assessment for complex biologics
Proven experience managing outsourced…
Position Requirements
10+ Years
work experience
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