The Role: Moderna is seeking a Technical Program Manager to lead validation strategy and execution for the digital platform supporting individualized neoantigen therapy (INT). This platform spans orchestration, scheduling, and integration systems that enable commercial manufacturing across Merck and Moderna for personalized therapies. In this role, you will be responsible for ensuring that digital systems are designed to meet Computer System Validation (CSV) expectations from the outset, not just tested after the fact. You will serve as the delivery lead for validation across key systems, ensuring they are inspection-ready for regulatory milestones such as BLA (Q1 2026) and First Market Release (H1 2027). This position requires strong partnership across QA, Regulatory, Digital, and Manufacturing teams, and offers the opportunity to shape validation practices for one of the most complex and meaningful spaces in biotechnology. Here's What You'll Do: * Lead CSV planning and execution across a suite of digital capabilities, including mINT Engine, Scheduler, Control Tower, and integrations with SAP, MES, and LIMS * Partner with Digital and Engineering teams to embed validation requirements early into system design and architecture, ensuring systems are built to pass CSV with confidence * Actively participate in technical and architecture discussions to de-risk validation challenges and promote audit-readiness throughout the development lifecycle * Develop and maintain validation deliverables (plans, risk assessments, traceability, protocols, reports) in alignment with GxP regulations (21 CFR Part 11, Annex 11) * Work closely with QA and Regulatory to ensure all validation artifacts support regulatory submissions and inspection readiness * Collaborate with system integrators and service providers to drive accountability and timely execution of validation milestones * Represent Digital in regulatory inspections, internal audits, and cross-functional forums related to validation readiness * Contribute to the definition and continuous improvement of Moderna's validation strategy for digital platforms in regulated manufacturing environments Here's What You'll Need: * Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field * 8+ years of experience in technical program management with strong emphasis on Computer System Validation in regulated environments * Deep knowledge of GxP, validation lifecycle, and regulatory frameworks for digital systems in pharma or biotech * Proven experience leading validation for complex, integrated digital ecosystems supporting manufacturing or quality operations * Ability to drive cross-functional alignment and communicate clearly across technical, QA, and business stakeholders Here's What You'll Bring to the Table: * Experience supporting validation in the context of personalized medicine, advanced therapies * Familiarity with orchestration platforms, manufacturing execution systems, and data integration tools (e.g., Boomi, SAP, MES, LIMS) * Working knowledge of Agile methodologies and DevOps practices in a validated environment * Strategic mindset with the ability to dive deep into delivery details and validation dependencies At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between. * Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs * A holistic approach to well-being, with access to fitness, mindfulness, and mental health support * Lifestyle Spending Accounts to personalize your well-being journey * Family planning and adoption benefits * Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown * Savings and investment opportunities * Location-specific perks and extras About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure 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 people are the driving force behind our scientific progress and our culture. Together, 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 modernatx.com/careers to learn more about our current opportunities. Our Working Model 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. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's 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. 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're 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 accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation 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 team at [email protected]. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-CK1 *