The posting
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. 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. We digitize everywhere possible using the power of code to maximize our impact on patients. Here’s What You’ll Bring to the Table: 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. Our Working Model As we build our company, we have always believed that an in-person culture is critical to our success. This role is 100% onsite, reflecting the importance of being physically present to support the work, collaborate closely with colleagues, and contribute to our site-based operations. Working onsite enables real-time collaboration, strong team connections, direct mentorship, and the hands-on partnership needed to deliver our mission. 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. 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. 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. 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 [email protected]. - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing [email protected] if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home
