15 set - 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
20 set - Orgiano
Cronoshare.it
20 set - Cecchini
Cronoshare.it
20 set - Cannitello
Cronoshare.it
20 set - Firenze
Cronoshare.it