Senior Analytical Scientist - Bioassay CGT/ATMP

Location: Europe, with hybrid and remote options

Salary: €59,000 minimum annual salary, with the final package aligned to the applicable local market and internal frameworks.

Company

hirify.global is an international research-focused biopharmaceutical group developing and commercializing innovative medicines, including treatments for rare and ultra-rare disorders.

What you will do

• Lead bioanalytical and potency assay strategies for gene editing and nucleic acid-based therapeutics.
• Design and oversee cell-based potency, functional gene-editing, and mechanism-based assays using primary cells, immortalized lines, reporter systems, and relevant readouts.
• Drive assay development from early research through late-stage and GMP applications, including qualification, validation, stability-indicating, and comparability studies.
• Contribute to analytical characterization packages and link potency data to critical quality attributes.
• Lead outsourced analytical development activities, including CRO/CDMO selection, governance, technical review, troubleshooting, risk management, and budget oversight.
• Prepare, review, and approve technical and regulatory documentation while supporting CMC development, lifecycle management, and cross-functional project execution.

Requirements

• Minimum MSc in biotechnology, biology, biochemistry, or a related field.
• 5–10 years of experience in the biotech or pharmaceutical industry, including exposure to gene editing, CGT/ATMPs, nucleic acid-based products, and lipid nanoparticles.
• Strong expertise in cell-based assays, potency method development, flow cytometry, reporter assays, gene-editing readouts, ligand-binding assays, and protein expression or quantification assays.
• Experience with analytical method development, validation, product characterization, statistical tools, bridging assays, reference standard qualification, and control strategies for complex biologics.
• Experience managing outsourced analytical development with CROs/CDMOs and ensuring data integrity, reproducibility, troubleshooting, and scientifically rigorous execution.
• Understanding of GMP, regulatory requirements, and the CMC development lifecycle, with strong technical writing, data review, communication, and stakeholder management skills.

Culture & Benefits

• Work in an international, matrix-based research and development environment focused on rare and ultra-rare diseases.
• Access to development resources and training.
• Benefits include pension, private medical insurance, wellbeing programs, flexible benefits, and work-life balance initiatives.
• Annual performance-based bonus eligibility.
• Flexible working arrangements, remote work options, relocation support, and tax assistance for foreign colleagues.