Senior QC Bioassay Scientist, Cell-Based Methods (cGMP)

Moderna Therapeutics; Madrid; Presencial; EUR 70.000 - 100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Healthcare

Well-being program

Family benefits

Paid time off

Location perks

Descripción de la vacante

Moderna Therapeutics in Madrid seeks a senior QC Bioassay professional to own cGMP data review for Cell‑Based Methods used in release and stability testing. You will ensure data integrity, review records, and drive investigations across QA, Manufacturing, and Digital teams.

As a senior contributor, you will mentor juniors, lead CAPAs and change controls, support method transfers, qualification, validation, and lifecycle activities.

Formación

• BA/BS in a scientific discipline.
• 4+ years Mammalian cell experience (or MS with 2+ years).
• Cell-based ELISA and in-vitro potency assays experience.
• GMP environment experience preferred.
• English proficiency required.

Responsabilidades

• Perform cGMP data review for QC Bioassay testing, focusing on Cell‑Based Methods for release and stability.
• Provide technical and compliance oversight of assay packages and lab records across paper and electronic systems.
• Lead and/or support laboratory investigations, OOS/OOT, deviations, and quality events.
• Lead CAPAs and change controls related to QC Bioassay.
• Support method transfers, qualification, acquisition, validation, and lifecycle activities for Cell‑Based Methods.
• Review, author, and approve GMP documentation including SOPs, reports, and training materials.
• Support stability programs and data trend analyses; investigate atypical results.
• Provide guidance to junior team members and act as senior technical and compliance point of contact.

Conocimientos

Mammalian Cell

ELISA

GMP Experience

English Proficiency

Educación

BA/BS in a scientific discipline

Descripción del empleo

Moderna Therapeutics in Madrid seeks a senior QC Bioassay professional to own cGMP data review for Cell‑Based Methods used in release and stability testing. You will ensure data integrity, review records, and drive investigations across QA, Manufacturing, and Digital teams.

As a senior contributor, you will mentor juniors, lead CAPAs and change controls, support method transfers, qualification, validation, and lifecycle activities.