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 /h3pChiesi Global Rare disease is recruiting for a Senior Analytical Scientist with deep expertise in development of complex analytical methods including bioassays and cell-based potency assays for the characterization of ATMP including oligonucleotides, lipid nanoparticle (LNP) based products and other modalities. /ppIn this role, you will be a key member of the CMC Extended Technical Team (ETT), operating in a matrix organisation and responsible for driving analytical development and control strategy for gene editing products within the GRD function from candidate selection though clinical development and toward commercial launch, while also supporting lifecycle management activities. /ph3You will be responsible for /h3ulliDefine and lead the development plan for bioanalytical and potency assay strategies for gene editing and nucleic acid-based therapeutics, acting as a subject matter expert (SME) in method development, validations and control strategies for the assigned projects /liliDrive fit-for-purpose assay development, evolving from early development to late-stage/GMP /liliDesign and oversee the development of cell-based potency assays (primary cells, immortalized lines,



reporter systems), functional assays for gene editing efficiency (e.g., knockout/knock-in models), mechanism-based assays reflecting biological activity (e.g., transfection, expression, editing efficiency) /liliImplement and oversee assay qualification/validation (accuracy, precision, specificity, linearity, robustness), stability-indicating and comparability assays /liliContribute to analytical characterization packages, linking potency to CQAs /liliAct as primary analytical lead for outsourced activities, including: selection and onboarding of CROs/CDMOs, including support in auditing and qualification /liliTechnical oversight and governance of external partners ensuring robust and scientifically sound follow-up of external activities, driving accountability and continuous improvement /liliProactive troubleshooting and risk management /liliReview of critical protocol, methods and data generated at the CDMO /liliManage analytical project budgets (CROs, CDMOs, consultants) /liliActively contributing to the advancement of the project being a key player within the CMC team and ensuring compliance with overall program, 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 relevant regulatory sections (IND, IMPD, IB) /liliActively contributing to the development of the department in line with GRD and GRD RD strategic goals, sharing knowledge, and best practices /li /ulh3You will need to have /h3ulliMinimum MSc in relevant field (biotechnology, biology, biochemistry or a related field) /lili5-10 years of experience in the biotech/pharmaceutical industry, with exposure to gene editing, CGT/ATMPs, nucleic acid-based products and lipid nano particles development /liliStrong expertise in: cell-based assays and potency method development for gene editing platforms and/or mRNA-LNP products and delivery-driven potency assays (critical requirement) /liliAdvanced Bioanalytical Techniques, i.e. Cell-based assays (flow cytometry, reporter assays), Gene editing readouts, ligand binding assays, protein expression/quantification assays /liliStatistical tools for assay performance /liliBridging assays and reference standard qualification /liliAnalytical method development, validation, and product characterization /liliControl strategy development for complex biologics /liliProven experience managing outsourced analytical development activities (CROs/CDMOs), including: technical oversight,



ensuring scientifically rigorous assay execution, data integrity and reproducibility /liliTroubleshooting and escalation management /liliCritical, data-driven performance follow-up /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. /ppThe minimum 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 to participate in 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, tax assistance services for foreign colleagues, all designed to help you thrive. /ph3Equal opportunity employer /h3pChiesi 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 Analytical Scientist - Bioassay CGT/ATMP (Europe, remote, IT) (Italia)
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