Sr. Specialist, Quality Control, Bioassay

The Role:

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.

Moderna is strengthening its international centre for analytical excellence in Madrid the largest of its kind outside the United States. The site supports our global manufacturing network and advancing mRNA portfolio. We welcome talent ready to drive innovative research and development.

This is an opportunity to become a senior technical and compliance voice within QC Bioassay in Madrid taking ownership of cGMP data review with a particular focus on Cell-Based Methods supporting release and stability testing. This is a site-based position working the 14:0022:00 shift. As a senior individual contributor and the primary QC Bioassay technical and compliance point of contact during these hours you will combine deep mammalian cell and bioassay expertise with rigorous application of cGMP data integrity and quality systems.

Your impact will extend beyond data review. You will lead and support complex laboratory investigations and quality events troubleshoot assays and laboratory systems contribute to method qualification acquisition transfer validation and lifecycle activities and help ensure continuity and prioritization of laboratory operations across shifts.

You will also have opportunities to work alongside Modernas evolving digital ecosystem and get closer to Generative AI-enabled tools exploring how emerging capabilities can support scientific knowledge data review trending documentation and laboratory efficiency while operating within appropriate GxP data integrity and quality requirements.

Heres What Youll Do:

• Heres What Youll 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 14:0022:00 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 14:0022:00 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 Modernas 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.

The key Moderna Mindsets youll need to succeed in the role:

• We obsess over learning. We dont have to be the smartest we have to learn the fastest.

• We act with dynamic range driving strategy and execution at the same time at every step.

Heres What Youll 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.

Our Working Model

As we build our company we have always believed that an in-person culture is critical to our success. This role is 100% onsite reflecting the importance of being physically present to support the work collaborate closely with colleagues and contribute to our site-based operations.

Working onsite enables real-time collaboration strong team connections direct mentorship and the hands-on partnership needed to deliver our mission. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.

Moderna is a smoke-free alcohol-free and drug-free work environment.

Pay & Benefits

At Moderna we believe that when you feel your best you can do your best work. Thats why our benefits and well-being resources are designed to support youat work at home and everywhere in between.

• Competitive healthcare plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being with access to fitness mindfulness and mental health support
• Family building benefits including fertility adoption and surrogacy support
• Generous paid time off including vacation bank holidays volunteer days sabbatical global recharge days and a discretionary year-end shutdown
• Savingsandinvestments to help you plan for the future
• Location-specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna

Since our founding in 2010 we have aspired to build the leading mRNA technology platform theinfrastructure to reimagine how medicines are created and delivered and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission values and mindsets every day our peopleare the driving force behind our scientific progress and our we are creating a culture of belonging and building an organization that cares deeply for our patients our employees the environment and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer a Fast Company Best Workplace for Innovators and a Great Place to Work in the U.S.

As we build our company we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.

If you want to make a difference and join a team that is changing the future of medicine we invite you to visit to learn more about our current opportunities.

Moderna is a smoke-free alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!

Moderna is committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry or citizenship ethnicity disability military or protected veteran status genetic information sexual orientation marital or familial status or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at .

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