Specialist, Quality Control

Job description

The Role: Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna is strengthening its presence in Marlborough, Massachusetts, a key hub for GMP clinical and commercial manufacturing. Our Marlborough facility supports end-to-end mRNA production, including drug substance and drug product manufacturing, enabled by advanced cleanroom environments, quality control laboratories, and integrated supply chain operations. We welcome talent committed to operational excellence, innovation, and delivering high-quality medicines to patients worldwide. Reporting to the Senior Manager/Manager of QC Sample Management, you will serve as a subject matter expert supporting Chemistry operations within Moderna’s Quality Control organization in Marlborough. As an individual contributor, you will provide technical and functional leadership across cGMP sample coordination, Chemistry testing, laboratory operations, quality systems, and cross-functional partnerships with internal and external laboratories, while remaining closely connected to hands-on laboratory work. Working Monday through Friday, you will help strengthen safe, compliant, efficient QC operations while advancing digital laboratory capabilities, including opportunities to work closely with LIMS, data-driven workflows, and emerging Generative AI tools that can support scientific and operational excellence. Here’s What You’ll Do: Provide technical and functional leadership to associates supporting QC Chemistry and various Development laboratories, while operating as an individual contributor rather than a direct people manager. Oversee laboratory and sample-management schedules to support the safe and timely completion of sample processing, Chemistry testing, data review, and associated quality records. Apply strong knowledge of HPLC testing and chromatogram analysis to support Chemistry operations, data interpretation, troubleshooting, and compliant execution of laboratory activities. Contribute directly to hands-on laboratory work while serving as a subject matter expert for cGMP sample coordination and testing activities. Coordinate cGMP samples and associated testing activities across internal teams and external laboratories, ensuring appropriate communication, traceability, compliance, and execution. Author and revise SOPs, protocols, and other controlled documentation required to support QC Chemistry and Sample Management operations. Author, investigate, and support quality-system records, including deviations, CAPAs, and change controls, ensuring issues are appropriately documented, assessed, and driven to resolution. Partner with Moderna’s Digital team to expand and optimize the use of the LabVantage LIMS platform, strengthening laboratory workflows, data integrity, traceability, and operational efficiency. Explore opportunities to work alongside Digital partners and emerging Generative AI-enabled tools to improve knowledge access, laboratory workflows, documentation, data review, and operational decision-making where appropriate within regulated processes. Collaborate with Quality Control teams to continuously improve the quality, compliance, efficiency, and scalability of QC operations. Provide subject matter expertise and operational support during internal and external audits, helping ensure laboratory activities, records, systems, and processes remain inspection-ready. Manage controlled temperature units (CTUs), including oversight, maintenance coordination, monitoring, and troubleshooting to support reliable sample and material storage. Lead technical troubleshooting and provide guidance and support to the Sample Management team when laboratory, operational, or compliance issues arise. Establish and maintain a safe laboratory working environment, reinforcing safe laboratory practices and appropriate execution of regulated activities. Support review of analytical and laboratory data and the generation of Certificates of Analysis (COAs), ensuring records are accurate, complete, and compliant with applicable quality requirements. Work cross-functionally with QC, Development, Digital, Quality, and internal and external laboratory partners to enable effective Chemistry operations and timely testing. The key Moderna Mindsets you’ll need to succeed in the role: “We act with dynamic range, driving strategy and execution at the same time at every step.” “We digitize everywhere possible using the power of code to maximize our impact on patients.” Here’s What You’ll Need (Basic Qualifications) BA/BS in a relevant scientific discipline with a minimum of 2-5 years (or MS in a relevant scientific discipline with a minimum of 0-3 years) Quality Control experience in a cGMP organization Demonstrate ability to effectively and independently prioritize, manage, and complete multiple projects and tasks in a fast-paced environment Detailed knowledge of LIMS system (LIMS) and quality document system (Veeva) Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations Experience with gowning, aseptic technique and general lab safety practices Flexible schedule to support periodic on call, weekend or holiday coverage Strong and effective people management skills 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. Moderna is committed to building a world-class QC function, and this role offers a unique opportunity to shape the future of quality control for one of Moderna’s most impactful programs. This is a high-impact opportunity to lead day-to-day QC operations and drive compliance and efficiency for one of Moderna's most critical functions. 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 $74,000.00 - $118,400.00. 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