Senior Technical Leader, Analytical Method Development and Validation, GRD CMC

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

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