ppSelect how often (in days) to receive an alert: /p h3Senior Technical Leader, Analytical Method Development and Validation, GRD CMC /h3 pDate: 12 Aug 2026 /p pBusiness Area: RD, Pharmacovigilance Regulatory Affairs /p pJob Type: Direct Employee /p pContract Type: Permanent /p pLocation: Parma, IT /p pbAbout us /b /p pChiesi 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. /p pAt 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 Vantaggi Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. /p pDiversity 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. /p pbChiesi Global Rare Diseases /b /p pChiesi 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. /p pThis unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma. /p pRare 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 . /p pbWhat we are looking for /b /p h3bThis is what you will do /b /h3 pAre 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. /p pAs 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.



/p h3bYou will be responsible for /b /h3 pIn 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. /p pYou 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. /p pIn this role, you will: /p ul liAct 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. /li liLead or contribute to CMC strategies from candidate selection through clinical supply, technology transfer, process characterization, validation, regulatory submission, launch, and lifecycle management. /li liProvide 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. /li liTranslate understanding of protein structure, function, expression, process parameters, and analytical data into risk-based CMC strategies and practical development decisions. /li liLead 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. /li liDrive phase-appropriate control strategies covering process parameters, in-process controls, release testing, characterization, comparability, specifications, and lifecycle knowledge management. /li liLead technical risk assessments, process change assessments, comparability strategies, troubleshooting, investigations, deviations, CAPAs, and continuous improvement activities related to biologics drug substance development. /li liLead scientific and technical discussions with internal stakeholders, CDMOs, CROs, academic partners, and external consultants, ensuring alignment on development plans, deliverables, risks, budget, and timelines. /li liSupport 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. /li liContribute to technical and regulatory documentation, business development and due diligence assessments, and the development of GRD CMC ways of working for protein biologics. /li /ul h3bYou will need to have /b /h3 pWe 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. /p pYou likely have: /p ul liA university degree in biotechnology, biochemistry, chemistry, biology, pharmacy, engineering, or a related scientific discipline; an advanced degree is an advantage. /li liSignificant 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. /li liStrong scientific understanding of analytical techniques relevant to biologics development, including assay performance, robustness, method lifecycle, data interpretation, and regulatory expectations for validated methods. /li liStrong understanding of GMP, regulatory expectations, quality systems, and development requirements for clinical and/or commercial manufacturing. /li liExperience working with CDMOs, CROs, external partners, or outsourced development and manufacturing models. /li liAbility to translate complex technical information into clear recommendations, fit-for-purpose plans, and practical decisions. /li liExperience leading technical discussions, coordinating cross-functional activities, and influencing stakeholders in a matrix environment. /li liExcellent written and verbal communication skills in English. /li /ul pTo 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. /p pYou 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. /p h3bLocation /b /h3 pEurope - Remote /p h3bCompensation range /b /h3 pThe 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. /p /p #J-18808-Ljbffr

📌 Senior Technical Leader, Analytical Method Development and Validation, GRD CMC (Parma)
🏢 Chiesi Farmaceutici
📍 Parma