Technical Program Manager
Technical Program Manager
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Salary Not Disclosed
1 Vacancy
Job Description
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 inspectionready 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.
Heres What Youll 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 derisk validation challenges and promote auditreadiness 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 crossfunctional forums related to validation readiness
Contribute to the definition and continuous improvement of Modernas validation strategy for digital platforms in regulated manufacturing environments
Heres What Youll Need:
Bachelors 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 crossfunctional alignment and communicate clearly across technical QA and business stakeholders
Heres What Youll 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. Thats why our US benefits and global wellbeing resources are designed to support youat work at home and everywhere in between.
- Bestinclass healthcare coverage plus a suite of voluntary benefit programs to support your unique needs
- A holistic approach to wellbeing with access to fitness mindfulness and mental health support
- Lifestyle Spending Accounts to personalize your wellbeing journey
- Family planning and adoption benefits
- Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary yearend shutdown
- Savings and investment opportunities
- Locationspecific 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 worldclass 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 to learn more about our current opportunities.
Our Working Model
As we build our company we have always believed an inperson culture is critical to our success. Moderna champions the significant benefits of inoffice collaboration by embracing a 70/30 work model. This 70% inoffice 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 smokefree alcoholfree and drugfree work environment.
Equal Opportunities
Moderna is committed to equal employment opportunity and nondiscrimination 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 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 EVerify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.
Accommodations
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 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 .
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 applicants ability to access exportcontrolled 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 nonU.S. persons to apply for an export control license.
#LICK1Required Experience:
Manager
Employment Type
Full-Time
