OverviewIn this GRD CMC role, you will shape analytical and CMC strategy for rare disease programs. You will work closely with science and development teams, external partners, and CROs to translate science into robust development plans and compliant execution. You will drive risk-based CMC decisions, lifecycle management, and ensure regulatory alignment across projects. This is an opportunity to lead transformative work in rare diseases at a mission-driven company.

Retribuzione / Benefits

annual premio schemecomprehensive benefits packageremote work optionsflexible benefits programmerelocation supporthealthcare programs

Responsabilità

Act as subject matter expert in analytical method development, qualification and validation, and CMC technical areas for biologicsLead or contribute to CMC strategies from candidate selection to clinical supply, tech transfer, validation, regulatory submission, launch, and lifecycle managementProvide guidance on expression systems, cell line development, purification, and process control for protein biologicsTranslate protein structure/function and process parameters into risk-based CMC strategies and practical development decisionsLead identification and management of critical quality attributes (potency, purity, identity, glycosylation, aggregates, impurities, host cell proteins/DNA, stability)Drive phase-appropriate control strategies,



release testing, comparability, specifications, and knowledge managementLead risk assessments, change assessments, comparability strategies, investigations, deviations, CAPAs, and continuous improvement for biologicsLead technical discussions with internal and external partners to align on development plans, risks, budget, and timelinesSupport selection, evaluation, and oversight of external development/manufacturing partnersContribute to technical and regulatory documentation and GRD CMC ways of working for protein biologics

Requisiti fondamentali

Significant experience in analytical method development, qualification and validation for biologics within CMC developmentStrong understanding of GMP, regulatory expectations, and quality systems for clinical and/or commercial manufacturingExperience working with CDMOs, CROs, or outsourced development modelsAbility to translate complex technical information into clear, practical plans and decisionsExperience leading cross-functional discussions and influencing stakeholders in matrix environmentsExcellent written and verbal English communicationCollaborativeAccountableProactiveAnalytical method development, qualification and validationAnalytical control strategy, stability, comparabilityTechnology transfer, process development, scale-up

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