Senior Analytical Scientist - Bioassay CGT/ATMP

Overview

In this role you drive analytical development for gene editing and nucleic acid-based therapeutics within the GRD CMC team. You lead method development and control strategies for complex modalities, including ATMPs and LNP-based products, collaborating across functions from candidate selection to clinical development and launch. You oversee outsourced activities, ensure data quality, and contribute to regulatory documentation. This position offers impact in shaping analytics for cutting-edge therapies in a global, matrix environment.

Retribuzione / Benefits

pension

private medical insurance

wellbeing programme

flexible benefits programme

remote work options

relocation support

Responsabilità

Define and lead bioanalytical and potency assay strategies for gene editing and nucleic acid therapeutics

Act as SME for method development, validation, and control strategies for assigned projects

Drive fit-for-purpose assay development from early to late-stage GMP

Design and oversee cell-based potency assays and functional assays for gene editing efficiency

Implement assay qualification/validation, stability-indicating and comparability assays

Lead outsourced analytical activities including CRO/CDMO selection and governance

Provide technical oversight of external partners and ensure robust follow-up of activities

Manage analytical project budgets for CROs/CDMOs and consultants

Write and review technical documentation (development protocols, reports, regulatory sections)

Requisiti fondamentali

MSc in biotechnology, biology, biochemistry or related field

5–10 years in biotech/pharma with exposure to gene editing, CGT/ATMPs, nucleic acid-based products and LNPs

Strong expertise in cell-based assays and potency method development for gene editing or m

RNA–LNP products

Advanced bioanalytical techniques (flow cytometry, reporter assays, gene editing readouts, binding and expression assays)

Statistical tools for assay performance and reference standard qualification

Analytical method development, validation, and product characterization

GMP/CMC development lifecycle knowledge and regulatory documentation experience

Experience managing outsourced analytical development (CROs/CDMOs)

Excellent communication, regulatory writing, and cross-functional collaboration skills

Hands-on, pragmatic, results-driven problem solver

strong communication

stakeholder management

problem-solving mindset

cell-based assays and potency assay development

gene editing readouts and delivery assays

LNP/nucleic acid-based product analytics