Senior Analytical Scientist - LNP/RNA analytics
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 reputed company purpose: promoting a healthier world for our people, patients, and the reputed company. This is what drives us as we research, reputed company, and market innovative drugs across our main therapeutic areas. Discover more here. At Chiesi we are thinking generations reputed company, 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 reputed company our differences reputed company 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 reputed company for the reputed company. Chiesi Global Rare Diseases Chiesi Global Rare Diseases is a reputed company’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 reputed company 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. reputed company are looking for This is what you will do Chiesi-Global Rare disease is reputed company for a Senior Analytical Scientist with deep expertise in development, optimization, and validation of reputed company analytical methods for the characterization of ATMP including oligonucleotides, mRNA 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 reputed company the GRD function from candidate selection though clinical development and toward reputed company launch, while also supporting lifecycle management activities. You will be responsible for Define and reputed company the development plan for analytical techniques used for RNA and nanoparticle characterization, including LC‑MS, HPLC‑CAD, DLS, electrophoretic methods and reputed company acting as a subject matter expert (SME) in method development, validations and control strategies for the assigned projects Design and reputed company method development, qualification, validation, and product characterization. reputed company a robust control strategies for mRNA–LNP products and modaliies (critical quality attributes, CQAs) Act as primary analytical reputed company for outsourced activities, including: Selection and reputed company of CROs/CDMOs, including support in auditing and qualification Technical reputed company and governance of external partners ensuring robust and scientifically sound follow-up of external activities, driving accountability and reputed company 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 reputed company the CMC team and ensuring compliance with overall program, budget and regulatory strategy Write, review, and approve technical documentation reputed company 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, biochemistry, analytical chemistry, chemical engineering or a reputed company 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 analytical methods and instruments for lipids, nanoparticle and nucleic acids characterization such as (critical requirement): UPLC/UHPLC method development for lipids and oligonucleotides; Ion-pair reversed-phase (IP-RP) chromatography; Size-exclusion chromatography (SEC) for LNP size and aggregation profiling DLS LC-MS, high resolution MS reputed company reputed company (NGS) or Sanger reputed company UV-Vis spectroscopy( Nanodrop) Electrophoretic methods : Capillary electrophoresis (CE-SDS, CE-UV), Gel electrophoresis (agarose, PAGE) and Fragment analysis and charge heterogeneity profiling Analytical method development, validation, and product characterization Control strategy development for reputed company biologics Proven experience managing outsourced analytical development activities (CROs/CDMOs), including: Technical reputed company 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 reputed company 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 reputed company in Europe, with both hybrid and remote options. Compensation reputed company 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 reputed company 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, reputed company to our established salary reputed company. 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. reputed company offer No matter where your path starts at Chiesi, it leads to inspiring reputed company. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with reputed company to resources and training every reputed company of the way. We reputed company top-class benefits, including comprehensive reputed company 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, reputed company designed to help you reputed company. Chiesi is an equal opportunity employer committed to hiring a diverse workforce at reputed company reputed company of our business. reputed company reputed company applicants receive consideration for employment based on attitude and merit, without regard to race, national reputed company, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other reputed company protected by applicable laws. This policy applies to reputed company aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination. Apply To This Job