07 ott - Reggio Emilia
Chiesi
Overview
In 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 / Benefits
- remote work options
- relocation support
- comprehensive healthcare programs
- pension
- wellbeing programme
- flexible working arrangements
Responsabilità
- Act 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 fondamentali
- Significant 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
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