Viral Safety Expert

ARTO; España; Presencial; EUR 70.000 - 98.000; Jornada completa

Descripción de la vacante

ARTO is partnering with a specialist biopharmaceutical organisation to recruit a Viral Safety Expert with strong Next-Generation Sequencing (NGS) expertise. The role focuses on GMP quality control, analytical method development and viral safety, with interpretation of NGS data across biologics and advanced therapies.

The successful candidate will support development, validation and transfer of analytical methods, while acting as an expert in applying NGS to viral safety testing and contributing

Formación

• Significant experience in GMP quality control and analytical method development.
• Demonstrable expertise in NGS data analysis and interpretation beyond sequencing technologies.
• Experience supporting regulatory submissions and interacting with health authorities across EU/US.

Responsabilidades

• Lead development, validation and transfer of analytical methods per GMP.
• Provide technical expertise in viral safety testing and NGS-based methodologies.
• Interpret sequencing outputs to identify contaminants, deviations and anomalies.
• Assess biological significance of findings and communicate conclusions to customers.
• Support reporting, data interpretation and the improvement of bioinformatics pipelines.
• Monitor regulatory developments and contribute to regulatory filings.

Conocimientos

GMP quality control

Analytical method development

NGS data analysis

Regulatory submissions

Herramientas

NGS analysis software

Descripción del empleo

We are partnering with a specialist biopharmaceutical organisation to recruit a Viral Safety Expert with strong Next-Generation Sequencing (NGS) expertise to join its growing team.

This is a technical and scientific opportunity for an experienced professional with a background in GMP quality control, analytical method development and viral safety, who can also demonstrate genuine expertise in interpreting NGS data.

The successful candidate will support the development, validation and transfer of analytical methods, while acting as a scientific expert in the application of NGS to viral safety testing across biologics and advanced therapies.

Key Responsibilities

• Lead the development, validation and transfer of analytical methods in accordance with GMP requirements.
• Provide technical expertise in viral safety testing and NGS-based methodologies.
• Interpret sequencing outputs to identify potential contaminants, genomic deviations and other anomalies.
• Assess the biological significance of findings and communicate clear conclusions to customers.
• Support scientific and technical reporting, data interpretation and the continuous improvement of bioinformatics pipelines.
• Monitor regulatory developments and contribute to the preparation and defence of regulatory files.
• Act as a technical point of contact during customer audits, regulatory inspections and discussions with health authorities.
• Support the introduction of new analytical technologies and contribute to the organisation’s wider scientific development.

About You

• Significant experience in GMP quality control and analytical method development, ideally within biopharmaceuticals, biologics or advanced therapies.
• Demonstrable expertise in NGS data analysis and interpretation, beyond exposure to sequencing technologies.
• Strong knowledge of virology, viral safety, molecular biology or viral genomics.
• Experience with analytical method development, validation, transfer and lifecycle management.
• Ability to interpret NGS findings and evaluate their potential biological and viral safety implications.
• Experience supporting regulatory submissions and interacting directly with health authorities, ideally across the EU and US.
• Confidence working with customers, external partners and internal stakeholders as a technical subject matter expert.
• Strong written and spoken English communication skills.

This role offers the opportunity to combine GMP analytical expertise, viral safety, NGS interpretation and regulatory engagement within an organisation developing innovative approaches to biopharmaceutical testing.