Specialist, Manufacturing
Job Description
The Role:
The Specialist, Manufacturing supports drug product operations by applying expertise in cGMP compliance, biopharmaceutical production processes, and operational excellence. Specialists own defined areas of focus across manufacturing unit operations and provide on-the-floor support for both routine and start-up activities. They drive investigations, lead improvements, support technology transfer, and act as technical SMEs. This role is critical to ensuring reliable, efficient, and compliant manufacturing operations.
Here's What You’ll Do
- Serve as a subject matter owner for specific manufacturing focus areas (e.g., component prep and formulation, fill/finish, visual inspection, label & packaging, MES, tech transfer, application of artificial intelligence, risk assessment, investigations, sampling, and regulatory inspections).
- Provide direct on-the-floor support to manufacturing operations as needed during start-up, routine production, and troubleshooting.
- Navigate complex cross-functional stakeholder interactions to drive alignment and ensure operational success.
- Lead and close technical investigations by identifying and resolving issues/deviations, determining root cause, implementing effective CAPAs, and serving as an SME who mentors and trains others to strengthen organizational capability.
- Develop, revise, and manage GMP documentation including batch records, SOPs, protocols, and reports.
- Support technology transfer activities, ensuring seamless introduction of new products, equipment, or processes.
- Drive operational readiness for new product introductions and major capital or modernization projects.
- Manage and execute change controls within the manufacturing organization.
- Participate in equipment start-up, commissioning, qualification, and validation.
- Drive continuous improvement using Lean/Six Sigma principles to enhance efficiency, reliability, compliance, and reduce operational variability while delivering measurable performance gains.
- Develop and track operational KPIs; communicate performance to management.
- Deliver training and coaching to manufacturing staff and SMEs across assigned functional areas.
- Ensure adherence to all regulatory standards, internal policies, and safety expectations.
- Support internal audits, external inspections, and readiness activities.
- Responsible for managing and enforcing finite scheduling and schedule adherence across projects, implementations, and clinical/commercial manufacturing activities.
Here’s What You’ll Need (Basic Qualifications)
- Education: Bachelor’s degree in Engineering, Life Sciences, or a related field. Advanced degree preferred.
- Experience: 5-8 years of experience in biopharmaceutical manufacturing operations, or a Master’s degree with 2-5 years of industry experience.
- Experience with deviation/investigation management systems and technical writing in a cGMP environment.
- Experience with buffer prep, formulation, aseptic manufacturing operations, isolator technology, media fills, automated visual inspection, automated labeling & packaging, or serialization preferred.
- This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.
- At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.
Here’s What You’ll Bring to the Table (Preferred Qualifications)
- Proficiency in Lean manufacturing methodologies and Six Sigma principles.
- Proficient in digital systems such as SAP, MES, and electronic batch records.
Pay & Benefits
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 voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
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-SB2-