Senior Technical Leader, Analytical Method Development and Validation, GRD CMC

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 Are you an experienced CMC professional who wants to help shape the future of rare disease development? In GRD CMC, we are building a dedicated technical leadership team with end-to-end responsibility for CMC strategy, execution, budget, and technical risk management across development projects, business development opportunities, and lifecycle activities. As part of the GRD CMC team, you will work close to science, projects, and decision-making. You will contribute to the development by translating scientific understanding into robust CMC strategies, practical development plans, and reliable technical execution. You will collaborate with internal functions, external CDMOs, CROs, and partners to ensure that products can progress efficiently from candidate selection through clinical development, technology transfer, regulatory submission, launch, and lifecycle management. You will be responsible for In this role, you will act as a senior technical leader and analytical CMC expert within GRD CMC. You will provide scientific and technical leadership for analytical method development, method qualification and validation, analytical control strategy, comparability, technology transfer, stability strategies, and lifecycle activities. You will lead an extended technical team and help ensure that analytical CMC deliverables are aligned with project objectives, regulatory expectations, quality requirements, timelines, and budget. You will play an important role in building and retaining product knowledge within GRD, enabling effective decision-making, supporting external partner oversight, and helping establish fit-for-purpose ways of working for rare disease development. In this role, you will: Act as subject matter expert within analytical method development, method qualification and validation, analytical control strategy, comparability, stability, and related CMC technical areas for biological products such as protein therapeutics. Lead or contribute to CMC strategies from candidate selection through clinical supply, technology transfer, process characterization, validation, regulatory submission, launch, and lifecycle management. Provide expert guidance on expression systems, cell line development, clone selection, cell banks, media and feed development, upstream process development, harvest, clarification, purification, impurity clearance, scale-up, and process control. Translate understanding of protein structure, function, expression, process parameters, and analytical data into risk-based CMC strategies and practical development decisions. Lead identification and management of critical quality attributes and key product quality attributes, including potency, purity, identity, glycosylation, charge variants, aggregation, fragments, process-related impurities, host cell proteins, host cell DNA, and stability. Drive phase-appropriate control strategies covering process parameters, in-process controls, release testing, characterization, comparability, specifications, and lifecycle knowledge management. Lead technical risk assessments, process change assessments, comparability strategies, troubleshooting, investigations, deviations, CAPAs, and continuous improvement activities related to biologics drug substance development. Lead scientific and technical discussions with internal stakeholders, CDMOs, CROs, academic partners, and external consultants, ensuring alignment on development plans, deliverables, risks, budget, and timelines. Support selection, evaluation, and oversight of external development and manufacturing partners by assessing technical capability, platform fit, manufacturing readiness, analytical capability, facility fit, and development risks. Contribute to technical and regulatory documentation, business development and due diligence assessments, and the development of GRD CMC ways of working for protein biologics. You will need to have We are looking for a scientifically strong, collaborative, and accountable CMC professional who enjoys working in a dynamic development environment. You combine deep technical and analytical expertise with the ability to see the broader project context, make risk-based recommendations, and create alignment across functions and partners. You likely have: · A university degree in biotechnology, biochemistry, chemistry, biology, pharmacy, engineering, or a related scientific discipline; an advanced degree is an advantage. Significant experience from analytical method development, method qualification and validation for biologics, including analytical control strategy, stability testing, comparability, technology transfer, or lifecycle management within CMC development. Strong scientific understanding of analytical techniques relevant to biologics development, including assay performance, robustness, method lifecycle, data interpretation, and regulatory expectations for validated methods. Strong understanding of GMP, regulatory expectations, quality systems, and development requirements for clinical and/or commercial manufacturing. Experience working with CDMOs, CROs, external partners, or outsourced development and manufacturing models. Ability to translate complex technical information into clear recommendations, fit-for-purpose plans, and practical decisions. Experience leading technical discussions, coordinating cross-functional activities, and influencing stakeholders in a matrix environment. Excellent written and verbal communication skills in English. To succeed in this role, you are proactive, solution-oriented, and comfortable taking responsibility in situations where priorities may evolve and not all answers are known from the start. You communicate clearly, build trust, and enjoy working with others to solve complex scientific and technical challenges. You are motivated by the opportunity to build something new, contribute to rare disease development, and ensure that critical CMC knowledge remains close to the projects and patients we serve. Location Europe - Remote 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 €68.480, 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 c 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.