Associate II, Quality Control
The Role
Moderna is seeking a Candidate based at their Marlborough, MA site. The Individual will support cGMP microbiology methods for QC raw material, plasmid, drug substance, Stability, finished product testing for mRNA products produced and Environmental and critical utilities monitoring at Moderna’s manufacturing facility. This individual will contribute to non-testing projects and activities as needed, such as document certification, monthly biosafety cabinet cleaning, etc.
Here's What You’ll Do
- Execute compendial microbiological testing, and other methodologies as needed.
- Perform methods such as Endotoxin, Bioburden, Environmental Monitoring, Microbial identification, Culture Purity, Support testing for in-process samples, drug substance and drug product, including generation of testing data to support clinical studies.
- Assist in development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements.
- Perform general laboratory support activities including reagent preparation, equipment maintenance, weekly and monthly cleaning of the BSCs.
- Stock and perform inventory of lab supplies.
- Establish and maintain a safe laboratory working environment.
Here’s What You’ll Need (Basic Qualifications)
- BS in a relevant scientific discipline with a minimum of 0 - 2 years (or MS in a relevant scientific discipline with 1 year) Quality Control experience in a cGMP organization.
- Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way.
- Familiarity with electronic databases (e.g. LIMS, SAP, LMS, or equivalent software).
- Strong written and oral communication skills as well as organizational skills.
- Ability to prioritize, manage and complete multiple projects and tasks in a fast-paced environment efficiently and independently.
- Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
Pay & Benefits
- 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 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 investments to help you plan for the future.
Location-Specific Perks and Extras
- 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.
Our Working Model
We believe 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.
About Moderna
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.
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.
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.