OverviewIn this role you will lead protein biologics drug substance development within GRD CMC, guiding expression systems, upstream/downstream processing, and product quality strategies.
You will direct technical teams, shape CMC development plans, and ensure alignment with regulatory and lifecycle needs.
Your work directly impacts robust development, transfer, and lifecycle management of protein therapeutics for rare diseases.
This is a chance to help shape patient-accessible therapies in a world-class, patient-focused biopharma environment.
Retribuzione / Benefitsremote work options
relocation support
comprehensive healthcare programs
pension
wellbeing programme
flexible working arrangements
ResponsabilitàAct as senior SME for protein biologics drug substance development with focus on expression, manufacturability, and quality
Lead or contribute to CMC strategies from candidate selection through clinical supply, transfer, characterization, validation, regulatory submission, launch, and lifecycle management
Provide guidance on expression systems, cell line development, clone selection, cell banks, media/feed development, upstream/downstream processing, purification, impurity clearance, scale-up, and process control
Translate protein structure/function and process/analytical data into risk-based CMC strategies and practical development decisions
Lead identification and management of critical and key product quality attributes (potency, purity, glycosylation, aggregation, host cell proteins/DNA, stability)




Drive phase-appropriate control strategies including in-process controls, release testing, comparability, specifications, and lifecycle knowledge management
Lead technical risk assessments, changes, comparability strategies, troubleshooting, deviations, CAPAs, and continuous improvement for biologics DS development
Lead scientific discussions with internal and external partners (CDMOs, CROs, academics) to align plans, risks, budget, and timelines
Support selection, evaluation, and oversight of external development/manufacturing partners based on capability and readiness
Contribute to GRD CMC technical/regulatory documentation and due diligence for business development and process improvements
Requisiti fondamentaliSignificant industrial experience in biologics CMC development with deep expertise in recombinant protein DS development, expression, and manufacturing
Strong understanding of upstream/downstream processing, protein characterization, analytical control strategies, GMP, regulatory expectations, comparability, validation, and lifecycle management
Experience working with CDMOs, CROs, academic partners, and outsourced development/manufacturing models
Proven ability to lead extended technical teams, coordinate cross-functional activities, influence stakeholders, and translate data into clear recommendations
Excellent written and verbal English communication skills
leadership
cross-functional collaboration
influencing stakeholders
recombinant protein drug substance development
protein expression systems
upstream/downstream process development

📌 Senior Technical Leader, Protein Biologics Development, Grd Cmc (Emilia-Romagna)
🏢 Chiesi
📍 Emilia-Romagna