Senior QC Bioassay Lead, Cell-Based Methods

BioSpace; Colmenar Viejo; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

Moderna Madrid QC Bioassay team seeks a senior scientist to lead cGMP data review for Cell-Based Methods supporting release and stability testing. This onsite role covers the 14:00–22:00 shift, acting as the primary technical and compliance contact during these hours.

Expect investigations, data integrity emphasis, and cross-functional collaboration across QA, Manufacturing and Digital teams. You will review SOPs and protocols, support method lifecycle activities, and contribute to continuous

Formación

• BA/BS in a scientific discipline is required.
• MS with 2+ years experience acceptable for advanced degree holders.
• Experience with cell-based ELISA and in vitro potency assays preferred.
• GMP/regulatory environment experience (FDA/EU guidelines) preferred.

Responsabilidades

• Perform cGMP data review for QC Bioassay, focusing on Cell-Based Methods.
• Provide technical/compliance oversight of assay packages and records.
• Lead/assist investigations, deviations, CAPAs, and change controls.
• Support method transfers, qualification, validation, and lifecycle activities.
• Review and approve GMP documents and training materials.
• Support stability data review, data trending, and performance monitoring.
• Collaborate cross-functionally to align priorities with manufacturing and QA.

Conocimientos

cGMP data review

Cell-Based Methods

Mammalian cell

Data integrity

Quality systems

GxP documentation

CAPA & Change controls

OOS/OOT investigations

Educación

BA/BS in a scientific discipline

MS in a relevant discipline

Herramientas

SOPs & GMP docs

Laboratory instrumentation basics

Descripción del empleo

Moderna Madrid QC Bioassay team seeks a senior scientist to lead cGMP data review for Cell-Based Methods supporting release and stability testing. This onsite role covers the 14:00–22:00 shift, acting as the primary technical and compliance contact during these hours.

Expect investigations, data integrity emphasis, and cross-functional collaboration across QA, Manufacturing and Digital teams. You will review SOPs and protocols, support method lifecycle activities, and contribute to continuous