Senior Specialist, Quality Control Bioassay

About the role

Moderna is strengthening its international centre for analytical excellence in Madrid, the largest outside the United States, which supports its global manufacturing network and mRNA portfolio. This role is a senior technical and compliance position in QC Bioassay, owning cGMP data review with a focus on Cell-Based Methods for release and stability testing. It is a senior individual contributor who leads and supports laboratory investigations, quality events, method transfers and validation, and works across QC, QA, Manufacturing, Technical Development and Digital.

Key responsibilities

• Perform cGMP data review for Cell-Based Methods supporting release and stability programs, ensuring accuracy, completeness, data integrity and compliance with approved methods, specifications, cGMP and GDP.
• Oversight of executed assay packages and laboratory records across paper and electronic systems, and timely resolution of issues.
• Lead and support investigations, OOS/OOT assessments, deviations and CAPAs, including root cause analysis and corrective and preventive actions.
• Support method transfers, qualification, acquisition, validation and lifecycle activities, and review, authorise and approve controlled GMP documentation such as SOPs, protocols and instrument qualification documents.
• Support stability programs, including review of stability data, trend assessment and investigation of atypical results.
• Provide data entry, verification and trending, and develop scheduling and status-monitoring tools for testing workload and capacity.
• Support inspection and audit readiness, and give technical guidance, coaching and training to junior team members.
• Act as a senior technical and compliance point of contact, manage escalations, and follow all GxP regulations, data integrity requirements and internal procedures.

Required profile

• BA/BS in a scientific discipline, or MS in a relevant scientific discipline with 2 years of experience.
• More than 4 years of experience, with a focus on mammalian cells.
• Experience with cell-based ELISA and in vitro potency assays.
• GMP environment experience preferred.
• Working knowledge of FDA, EU and ICH guidelines preferred.
• Proficiency in English, verbal and/or written, required.

The role is 100% onsite in Madrid. Candidates should apply in English and attach an English version of their CV.