Senior Process Scientist - LNP process development

Job description

About us 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 lipid nanoparticle (LNP) formulations for nucleic acid delivery. 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 formulation development and lipids and exipient screening, process development, manufacturing and controls strategy for LNP platforms, acting as a subject matter expert (SME) for the assigned projects. Design and oversee the LNP development workstream supporting technology transfers of manufacturing processes and 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, Technical oversight and governance of external partners, ensuring robust and scientifically sound execution 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 review 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 , deviation assessments, 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 development of LNP based delivery systems Strong expertise in: Formulation screening/optimization, process development, scale-up, tech transfer to GMP manufacturing and process validation for LNP formulations (critical requirement) critical formulation and process parameters (FRR, TFR, lipid ratios) and their linkage to CQAs (size distribution, PDI, encapsulation efficiency, potency) multiple manufacturing technologies (microfluidics, T-mixers, inline mixing, continuous processing) and selection rationale for scale QbD-based development (DoE, CPP/CQA identification) Control strategy development and risk assessment for complex biologics Proven experience managing outsourced development activities (CROs/CDMOs), including: Technical oversight including review and approval of batch records, SOPs, development reports, and validation protocols 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 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. The budgeted salary range approved for this role is between €59.000 and €74.000. This range reflects the typical compensation expected for candidates with the experience and expertise required for the position. Final offer may vary based on the selected candidate's skills, experience, qualifications, overall profile, and internal equity considerations. This role is eligible to participate in an annual bonus scheme, subject to company and individual performance. In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme and more. What we offer No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive. Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.