Senior Technical Leader, Analytical Method Development and Validation, GRD CMC Business Area: R&D;, Pharmacovigilance & Regulatory Affairs Contract Type: Permanent Chiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose.

As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. We believe our differences make us stronger.

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.

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. 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.

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. 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.

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.

Experience leading technical discussions, coordinating cross-functional activities, and influencing stakeholders in a matrix environment. Excellent written and verbal communication skills in English. 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.

Europe - Remote Where the role is offered in a different country, the applicable salary, premio 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. #

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