Manufacturing Associate II, DP Operations, Visual Inspection, Label and Packaging

The Role

In this role you will be responsible for supporting execution across visual inspection labeling and packaging operations. The role ensures floor-level performance that meets cGMP expectations and supports right-first-time delivery through strong documentation practices adherence to procedures and training support. The MA II is accountable for the accuracy of SOPs MES/paper batch records and for owning quality system records tied to their operational area. This individual will maintain a strong floor presence to coach team members troubleshoot issues in real time and help drive operational readiness. The MA II is also expected to lead operational activities when required including new product introductions campaign start-ups or high-impact process execution. This role plays a critical part in supporting consistent commercial and clinical supply within a regulated manufacturing environment.

Heres What Youll Do

• 1. Floor Leadership & Execution Oversight

• Support and oversee manufacturing activities for visual inspection labeling and packaging to ensure execution and compliance.

• Provide real-time coaching and training to manufacturing staff on execution cGMP and safety.

• Act as the manufacturing lead during tech transfers new product introductions and major capital projects.

• Escalate any issues that may impact business objectives or batch delivery timelines.

• 2. Documentation & SOP Management

• Generate own and review SOPs related to all operational aspects including component prep formulation inspection and packaging.

• Ensure SOPs and batch records (paper and MES) are accurate clear and up to date.

• Lead dry runs and challenge SOPs on the floor incorporating feedback from cross-shift and rotation staff.

• Ensure SOPs are available on time to support operational readiness.

• 3. Training & Change Management

• Provide timely training to staff for SOP revisions ensuring all updates are delivered within target metric day.

• Develop training materials in collaboration with SMEs and support certification through OJTs.

• Deliver hyper care for new or critical processes during the ramp-up phase.

• 4. Quality & Compliance

• Own and manage Quality Records related to manufacturing (Deviations Change Controls CAPAs).

• Support regulatory and internal audits including presentation of processes SOPs training records and MES designs.

• Provide assessments for deviations CAPAs and change controls associated with manufacturing operations.

• 5. MES & Batch Record Integration

• Collaborate with the MES team to trigger or implement MES revisions in response to paper batch record updates.

• Act as a liaison for MES-related design feedback and process accuracy.

• 6. Process Improvement & Optimization

• Lead process improvement projects for visual inspection labeling and packaging operations.

• Drive initiatives for operational efficiency paperless operations and system integration.

• Monitor and review process alarms (e.g. batch deviations environmental alarms) and recommend actions.

• 7. Project & Readiness Management

• Support equipment start-up commissioning and validation efforts.

• Prepare operations for tech transfers and large-scale readiness projects.

• Onboard new materials including the development of BOMs and consumables lists for batch readiness.

• Engage in forums for prioritizing continuous improvement initiatives or business needs.

• 8. Availability & Flexibility

• Provide 24/7 on-call support for off-hour troubleshooting unclear instruction resolution and triage needs.

• Maintain a flexible work schedule to support manufacturing timelines and project deliverables.

• Additional duties as may be assigned from time to time

Heres What Youll Need (Basic Qualifications)

• Education: BS in a relevant science or engineering discipline.

• Experience: 2-3 years in cGMP pharmaceutical manufacturing with direct hands-on experience in:

• Visual inspection of filled units (manual and automated)

• Labeling operations (including label control and reconciliation)

• Secondary packaging of drug products for clinical or commercial use

Heres What Youll Bring to the Table (Preferred Qualifications)

• Specific Certifications or Training: Strong understanding of regulatory expectations for inspection labeling and packaging (FDA EMA etc.).

• Other Quantifiable Preference:

• Experience leading or supporting tech transfers process improvements and equipment start-ups in a manufacturing environment.

• Familiarity with MES systems batch record execution and deviation/CAPA processes.

• Proven ability to supervise and coach floor staff troubleshoot in real time and drive operational results.

• Excellent written and verbal communication skills; able to interact effectively across functions and levels.

• Strong problem-solving decision-making and organizational skills with a continuous improvement mindset.

• A desire to make an impact as part of a high-growth transformational company that is Bold Relentless Curious and Collaborative.

• This position is site-based requiring you to be at Modernas site full-time. This position is not eligible for remote work.

At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat 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 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 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 E-Verify 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 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.