Senior Analytical Scientist - Bioassay CGT/ATMP

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 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. In 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. You will be responsible for Define 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 Drive fit-for-purpose assay development, evolving from early development to late-stage/GMP Design 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) Implement and oversee assay qualification/validation (accuracy, precision, specificity, linearity, robustness), stability-indicating and comparability assays, Contribute to analytical characterization packages, linking potency to CQAs Act as primary analytical lead for outsourced activities, including: Selection and onboarding of CROs/CDMOs, including support in auditing and qualification Technical oversight and governance of external partners ensuring robust and scientifically sound follow-up of external activities, driving accountability and continuous improvement. Proactive troubleshooting and risk management Review of critical protocol, methods and data generated at the CDMO Manage analytical project budgets (CROs, CDMOs, consultants). Actively 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 Write, 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) Actively contributing to the development of the department in line with GRD and GRD R&D strategic goals, sharing knowledge, and best practices. You will need to have Minimum MSc in relevant field (biotechnology, biology, biochemistry or a related field) 5-10 years of of experience in the biotech/pharmaceutical industry, with exposure to gene editing, CGT/ATMPs, nucleic acid-based products and lipid nano particles development, Strong 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) Advanced Bioanalytical Techniques, i.e. Cell-based assays (flow cytometry, reporter assays), Gene editing readouts, ligand binding assays, protein expression/quantification assays. Statistical tools for assay performance Bridging assays and reference standard qualification Analytical method development, validation, and product characterization Control strategy development for complex biologics Proven experience managing outsourced analytical development activities (CROs/CDMOs), including: Technical oversight, ensuring scientifically rigorous assay execution, data integrity and reproducibility Troubleshooting and escalation management Critical, data-driven performance follow-up 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 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. 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.