Senior Technical Leader, Analytical Method Development And Validation, Grd Cmc
Pubblicato il 28-09-2026 - Chiesi in Parma
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 premio scheme
comprehensive benefits package
remote work options
flexible benefits programme
relocation support
healthcare programs
Responsabilità
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
Requisiti fondamentali
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