Principal Research Associate, Analytical Development

Job description

The Role In this role, you will support microbiology method development and lifecycle activities within Analytical Development for mRNA-based vaccines and therapeutics. You will apply hands-on expertise in microbiological methods including bioburden, endotoxin, sterility, and environmental monitoring to execute method development, optimization, characterization, qualification, and validation studies. You will work closely with Analytical Development scientists and cross-functional partners to evaluate method performance, troubleshoot technical challenges, support investigations and regulatory questions, and advance robust microbiological methods toward implementation in Quality Control. Success in this role requires strong laboratory execution, scientific problem-solving, attention to data quality and documentation, and effective collaboration across CMC Development and Quality. Here’s What You’ll Do Execute microbiological method development, optimization, characterization, qualification, and validation studies for bioburden, endotoxin, sterility, environmental monitoring, and related microbiological methods. Independently plan and execute defined experimental studies; analyze and interpret data, identify sources of variability, troubleshoot technical issues, and recommend experimental next steps. Evaluate method performance and suitability for intended use across relevant materials and sample types to support development, qualification, validation, and method lifecycle activities. Author and execute study protocols and methods and contribute to technical reports, development summaries, validation documentation, and other analytical documentation. Perform microbiological testing as part of method development, qualification/validation studies, investigations, troubleshooting, and other non-routine technical assessments. Support microbiological investigations, deviations, method troubleshooting, and root-cause assessments in partnership with AD, AS&T, QC, Quality, Process Development, and other cross-functional teams. Provide microbiology technical support for development programs, including technical assessments, risk evaluations, regulatory questions/RTQs, and preparation of supporting data and documentation. Support method transfer and implementation in internal and external QC laboratories and provide technical support during method lifecycle activities. Contribute to the evaluation and implementation of alternative or rapid microbiological methods, new technologies, and automation approaches that improve method performance, efficiency, or turnaround time. Communicate experimental results, conclusions, risks, and recommendations to technical and cross-functional stakeholders while maintaining high standards for laboratory safety, data integrity, and documentation. Here’s What You’ll Need (Basic Qualifications) M.S. in Microbiology, Biology, Molecular Biology, Biochemistry, Biotechnology, or a related field with 4+ years of relevant experience; or B.S./B.A. with 6+ years of relevant industry experience. Hands-on experience with microbiological methods and analytical method development, qualification, validation, or troubleshooting is required. Here’s What You’ll Bring to the Table (Preferred Qualifications) Hands-on experience with microbiological methods including bioburden, bacterial endotoxin, and sterility; environmental monitoring experience is desirable. Experience developing, optimizing, characterizing, qualifying, or validating microbiological methods in a biotechnology or pharmaceutical environment. Understanding of microbiological method performance, suitability, controls, interference, recovery, variability, and fitness for intended use. Experience in troubleshooting microbiological methods and supporting laboratory investigations, deviations, and root-cause assessments. Familiarity with USP and other applicable compendial and regulatory expectations for microbiological methods. Experience supporting method transfer and implementation in QC or external testing laboratories. Experience with rapid or alternative microbiological methods, microbial identification, or related technologies is desirable. Experience with mRNA, lipid nanoparticles, vaccines, biologics, or other advanced therapeutic modalities is preferred. Strong data analysis, problem-solving, written and verbal communication skills, with the ability to clearly document and communicate experimental results. Behaves like an owner, self-motivated and organized, with the ability to manage multiple laboratory priorities while maintaining scientific rigor, data integrity, and high-quality documentation. 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 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 The salary range for this role is $89,900.00 - $143,800.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. 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. 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 orientati