Sr. Specialist, Quality Control, Bioassay

Sr. Specialist, Quality Control, Bioassay

Moderna

Madrid, Spain

Here's What You'll Do:

• Perform cGMP data review for QC Bioassay testing, with a primary focus on Cell-Based Methods supporting release and stability programs, ensuring accuracy, completeness, data integrity, and compliance with approved methods, specifications, cGMP, and GDP requirements.
• Provide technical and compliance oversight of executed assay packages and associated laboratory records across both paper and electronic systems, ensuring appropriate documentation and timely resolution of identified issues.
• Lead and/or support laboratory investigations, OOS/OOT assessments, deviations, and other quality events associated with QC Bioassay activities, including root cause analysis, impact assessment, identification of corrective and preventive actions, and timely closure of records.
• Lead and/or support CAPAs and change controls related to the QC Bioassay area, ensuring appropriate implementation, effectiveness, and compliance with applicable procedures and regulatory requirements.
• Provide scientific and technical expertise for Cell-Based Methods, including troubleshooting methods, assays, equipment, and laboratory systems, and support the identification and implementation of sustainable corrective actions.
• Support method transfers, method qualification, method acquisition, validation, and method lifecycle activities, with particular emphasis on Cell-Based Methods.
• Review, author, and/or approve controlled GMP documentation, including SOPs, protocols, reports, QC release documentation, instrument qualification documentation, training materials, and method lifecycle documents, as applicable.
• Support stability programs, including review of stability testing data, assessment of trends, preparation and review of stability data packages, and investigation of unexpected or atypical results as needed.
• Perform data entry, data verification, and trending activities to support monitoring of assay performance and laboratory performance, and to identify emerging trends.
• Participate in cross-functional planning activities to align QC Bioassay priorities, resources, testing capacity, and constraints with manufacturing, release, stability, and broader business objectives.
• Develop, maintain, and/or support scheduling and status-monitoring tools to provide visibility of testing workload, capacity, turnaround times, priorities, and progress to the broader organization.
• Provide guidance and compliance support to the QC Bioassay team, proactively identifying potential compliance risks and supporting implementation of appropriate actions.
• Support inspection and audit readiness activities, including preparation for regulatory inspections and internal and external audits, provision of supporting documentation, and preparation and follow-up of responses and commitments.
• As a senior individual contributor, provide technical guidance, coaching, and training to junior team members, particularly in Cell-Based Methods, cGMP data review, troubleshooting, documentation, and quality systems.
• Serve as the Senior Specialist and primary technical and compliance point of contact for QC Bioassay during the 14:00–22:00 shift, providing senior-level support for laboratory operations and ensuring the timely management and escalation of laboratory investigations, deviations, OOS/OOT events, and other quality or operational issues identified during the shift.
• Ensure continuity of laboratory operations throughout the 14:00–22:00 shift, maintaining appropriate prioritization of testing and quality activities and enabling effective handover and communication between shifts.
• Collaborate cross-functionally with QC, QA, Manufacturing, Technical Development, Digital, and other relevant functions to resolve laboratory, technical, quality, and compliance issues.
• Complete and maintain accurate, contemporaneous, and compliant cGMP documentation for all activities performed.
• Follow all applicable GxP regulations, regulatory guidelines, internal procedures, and company policies, ensuring compliance with both regulatory and internal requirements.
• Execute activities in accordance with approved internal procedures, including Standard Operating Procedures, test methods, work instructions, specifications, protocols, and other applicable controlled documents.
• Adhere to Good Documentation Practices and Data Integrity requirements to ensure laboratory data, documentation, and records are accurate, complete, attributable, contemporaneous, and readily available to support routine operations, audits, and regulatory inspections.
• Support special projects, continuous improvement initiatives, and other QC Bioassay activities as assigned, contributing to improvements in laboratory efficiency, compliance, robustness, and operational performance.
• Engage with Moderna’s evolving digital ecosystem and opportunities to use Generative AI-enabled tools, where appropriate, to support scientific knowledge, data review, trending, documentation, and laboratory efficiency while maintaining the controls, data integrity, and quality standards required within a regulated GxP environment.

Here’s What You’ll Bring to the Table:

• BA/BS in a scientific discipline.
• Working experience: +4 years (or MS in a relevant scientific discipline with 2 years) with a focus in Mammalian Cell.
• Experience with cell-based ELISA and in vitro potency assays.
• Working experience in a GMP environment is preferred.
• Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
• Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
• Proficiency in English (verbal and/or written) required due to global collaboration needs."