Moderna
Analyst, Quality Control, Microbiology
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The Role
Reporting to the Manager, Microbiology, the Individual will perform routine environmental monitoring (EM) and water sampling of the GMP manufacturing facility. The analyst will also support microbiological testing for GMP QC raw materials, excipients, drug substances, and drug product intermediates for mRNA products produced at Moderna’s manufacturing facility and affiliated contract organizations. This position will contribute to related method transfers and qualification activities. The QC Analyst may perform projects as assigned.
Here’s What You’ll Do
- Perform routine environmental monitoring and critical utility sampling activities.
- Conduct analysis of water samples to include TOC, Conductivity, Bioburden, and Endotoxin.
- Execute GMP QC Microbiology methods, focusing on Sterility testing, Bioburden analysis, Endotoxin, and other methodologies as needed.
- Support testing for release, stability, and method and verification/validation samples.
- Collaborate with AS&T groups on new methods transfers. Participate in method transfer projects for internal and external testing labs.
- Assist in development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements
- Provide support to audit teams for internal and vendor audits
- Prepare and ship/receive contract laboratory testing samples including those intended for microbiological identification
- Perform general laboratory support activities including reagent preparation, equipment maintenance, and housekeeping.
- May participate in equipment and method qualifications, validations, and method transfers
- Perform data entry utilizing good documentation practices
- May assist with troubleshooting assay methods and equipment. Supports more junior staff with data review, training, and troubleshooting.
- Participate in authoring quality systems records such as EM excursions, investigation, deviations, change controls, CAPAs; Write/revise SOPs, protocols, and reports.
- Foster a positive and inclusive work 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 but not limited to standard operating procedures (SOPs) and work instructions.
- Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
- Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
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The Key Moderna Mindsets You’ll Need to Succeed in the Role
- We obsess over learning. We don’t have to be the smartest—we have to learn the fastest.
- In a technically evolving Quality Control environment, your success will depend on your ability to rapidly absorb new testing technologies, regulatory standards, and evolving data workflows. Your mindset must be tuned to constant growth and curiosity.
- We digitize everywhere possible using the power of code to maximize our impact on patients.
- This role engages heavily with digital platforms like LIMS for sample tracking, inventory control, and data analysis. Embracing digital workflows and analytical tools is key to ensuring speed, precision, and scalability in QC operations
Here’s What You’ll Need (Basic Qualifications)
- BSc in a relevant scientific discipline with a minimum of 2 years Quality Control experience in a cGMP organization with a focus on Microbiology.
- Hands-on experience of various Microbiology testing techniques and analyses (e.g. Vitek, Isolator Technology, Bioburden, BET, Sterility, others)
- Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred.
- Working experience in a GMP environment.
- 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.
- Proven ability to conduct investigations.
- As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre-employment check.
- This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.
Pay & Benefits
At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at 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
- Savings and investments 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, 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.
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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.
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.
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.
Moderna is a smoke-free, alcohol-free, and drug-free work environment.
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 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. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
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 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 leavesandaccommodations@modernatx.com.
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