Sr. Specialist, Sample Management

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.

Reporting to the Manager of Quality Control Operations you will take ownership of end-to-end QC Sample Management helping ensure Chemistry Microbiology and Bioassay samples move safely accurately and efficiently across Moderna and its external manufacturing network.

As an individual contributor and subject matter expert for Sample Management you will connect QC laboratories External QC Regulatory Operations Manufacturing Quality Assurance Supply Chain and CMO partners translating complex sample requirements into coordinated execution while maintaining rigorous cGMP standards. This is a highly hands-on opportunity to combine laboratory operations quality systems controlled-temperature unit management and digital innovation including partnering with Digital colleagues to optimize LIMS and gaining exposure to Generative AI tools that can support the evolution of QC operations.

Heres What Youll Do:

• Define implement and maintain an end-to-end sample management process for QC Chemistry Microbiology and Bioassay samples received internally from Moderna sites and from CMO sites.
• Serve as a key point of contact and subject matter expert for Sample Management partnering cross-functionally with QC laboratories External QC Regulatory Operations Manufacturing Quality Assurance Supply Chain and CMO partners to align sample-related activities priorities requirements and timelines.
• Coordinate and facilitate the cross-functional resolution of sample management issues ensuring appropriate communication escalation and follow-up with relevant stakeholders.
• Monitor and ensure the safe and timely execution of daily sample processing activities and accurate completion of associated quality records.
• Author and revise SOPs protocols and quality system records including deviations CAPAs and change controls.
• Create weekly sample management schedules and run periodic alignment meetings with internal stakeholders and external partners as required.
• Partner with the Digital team to expand and optimize the use of the LIMS system while exploring opportunities to get closer to Generative AI tools and emerging digital capabilities that can further enhance QC workflows knowledge and operational efficiency.
• Work closely with Quality Control laboratory teams to continuously improve the quality compliance and efficiency of laboratory sample operations.
• Provide support to audit teams during internal and external audits.
• Perform general laboratory support activities as required including housekeeping.
• Manage controlled-temperature units including their maintenance and troubleshooting.
• Lead troubleshooting activities and provide guidance and support to the sample management process when compliance issues arise.
• Train colleagues oversee team training assignments and help ensure compliance requirements remain current.
• Establish and maintain a safe laboratory working environment.
• Foster a positive and inclusive working culture that promotes collaboration innovation and continuous improvement.
• Follow all relevant GxP regulations guidelines and company policies to ensure compliance with regulatory and internal requirements.
• Execute tasks precisely as defined in internal guiding documents including standard operating procedures and work instructions.
• Follow Good Documentation Practices and Data Integrity requirements ensuring data documentation and records are completed and maintained appropriately for business use and are available to support audits or inspections.
• Complete training within the assigned required learning plan according to defined timelines and prescribed requalification cadence.

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

• We act with dynamic range driving strategy and execution at the same time at every step.
• We digitize everywhere possible using the power of code to maximize our impact on patients.

Heres What Youll Bring to the Table:

• Minimum: BA/BSc in a relevant scientific discipline
• At least 5 years in Quality Control in a cGMP organization.
• Strong working experience in a GMP environment.
• 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.
• undefined

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.

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 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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