ph3About us /h3pChiesi 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. /ppAt 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. /ppDiversity 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. /ph3Chiesi Global Rare Diseases /h3pChiesi 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. /ppThis unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma. /ppRare 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 . /ph3What we are looking for /h3h3This is what you will do /h3ulliDefine 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. /liliDesign and oversee the LNP development workstream supporting technology transfers of manufacturing processes and acting as the lead for outsourced process development activities, including: /liliScreening, selection and onboarding of suitable CROs/CDMOs; support in auditing and qualification /liliProviding 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 /liliLead root cause investigations and deviation assessments /liliReviewing technical plans,



batch records, SOP and reports review generated at the CDMO /liliManaging process development project budgets (CROs, CDMOs, consultants). /liliActively 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. /liliWrite, 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) /liliSupport the critical evaluation of external business development opportunities, focusing on process development and control for oligonucleotides. /liliParticipate in continuous improvement and life cycle management activities. /liliActively contributing to the development of the department in line with GRD and GRD RD strategic goals, sharing knowledge, and best practices within department and to relevant adjacent functions at Chiesi. /li /ulh3You will need to have /h3ulliMinimum MSc in a relevant field (biotechnology, bioengineering, biology, biochemistry, chemistry, chemical engineering or a related field) /lili5-10 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 /liliStrong expertise in:ulliFormulation screening/optimization, process development, scale-up, tech transfer to GMP manufacturing and process validation for LNP formulations (critical requirement) /lilicritical formulation and process parameters (FRR, TFR, lipid ratios) and their linkage to CQAs (size distribution, PDI, encapsulation efficiency, potency) /lilimultiple manufacturing technologies (microfluidics, T-mixers, inline mixing, continuous processing) and selection rationale for scale /liliQbD-based development (DoE, CPP/CQA identification) /liliControl strategy development and risk assessment for complex biologics /li /ul /liliProven experience managing outsourced development activities (CROs/CDMOs), including:ulliTechnical oversight including review and approval of batch records, SOPs, development reports, and validation protocols /liliTroubleshooting and escalation management /liliCritical and data-driven performance monitoring /li /ul /liliSolid understanding of GMP,



regulatory requirements, and CMC development lifecycle. /liliDemonstrated ability to operate effectively in a matrix organization and influence cross-functional teams. /liliStrong skills in technical writing, data review, and regulatory documentation. /liliExcellent problem-solving mindset with a hands‑on, pragmatic, and results‑driven approach. /liliStrong communication and stakeholder management skills in an international environment. /li /ulh3Location /h3pThis position can be based anywhere in Europe, with both hybrid and remote options. /ph3Compensation range /h3pThe 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. /ppTheminimum salary for this role is €59.000, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations. /ppThis role is eligible toparticipatein an annual premio scheme, subject to company and individual performance. /ppIn addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme and more. /ph3What we offer /h3pNo 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. /ppWe 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. /ppChiesi 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. /p /p #J-18808-Ljbffr

📌 Senior Process Scientist - LNP process development (Europe, remote, IT) (Italia)
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📍 Italia