Senior Technical Leader, Analytical Method Development and Validation, GRD CMC
Chiesi
Overview
In 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 bonus scheme
- comprehensive benefits package
- remote work options
- flexible benefits programme
- relocation support
- healthcare programs
- Act as subject matter expert in analytical method development, qualification and validation, and CMC technical areas for biologics
- Lead or contribute to CMC strategies from candidate selection to clinical supply, tech transfer, validation, regulatory submission, launch, and lifecycle management
- Provide guidance on expression systems, cell line development, purification, and process control for protein biologics
- Translate protein structure/function and process parameters into risk-based CMC strategies and practical development decisions
- Lead 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 management
- Lead risk assessments, change assessments, comparability strategies, investigations, deviations, CAPAs, and continuous improvement for biologics
- Lead technical discussions with internal and external partners to align on development plans, risks, budget, and timelines
- Support selection, evaluation, and oversight of external development/manufacturing partners
- Contribute to technical and regulatory documentation and GRD CMC ways of working for protein biologics
- Significant experience in analytical method development, qualification and validation for biologics within CMC development
- Strong understanding of GMP, regulatory expectations, and quality systems for clinical and/or commercial manufacturing
- Experience working with CDMOs, CROs, or outsourced development models
- Ability to translate complex technical information into clear, practical plans and decisions
- Experience leading cross-functional discussions and influencing stakeholders in matrix environments
- Excellent written and verbal English communication
- Collaborative
- Accountable
- Proactive
- Analytical method development, qualification and validation
- Analytical control strategy, stability, comparability
- Technology transfer, process development, scale-up
Offerta di lavoro pubblicata 2 giorni fa
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