Specialist, Manufacturing

About the role

The Specialist, Manufacturing supports drug product operations by applying expertise in cGMP compliance, biopharmaceutical production processes, and operational excellence. Specialists own defined areas of focus across manufacturing unit operations and provide on-the-floor support for both routine and start-up activities. They drive investigations, lead improvements, support technology transfer, and act as technical SMEs. This role is critical to ensuring reliable, efficient, and compliant manufacturing operations. Here's What You'll Do Serve as a subject matter owner for specific manufacturing focus areas (e.g., component prep and formulation, fill/finish, visual inspection, label & packaging, MES, tech transfer, application of artificial intelligence, risk assessment, investigations, sampling, and regulatory inspections). Provide direct on-the-floor support to manufacturing operations as needed during start-up, routine production, and troubleshooting. Navigate complex cross-functional stakeholder interactions to drive alignment and ensure operational success. Lead and close technical investigations by identifying and resolving issues/deviations, determining root cause, implementing effective CAPAs, and serving as an SME who mentors and trains others to strengthen organizational capability. Develop, revise, and manage GMP documentation including batch records, SOPs, protocols, and reports. Support technology transfer activities, ensuring seamless introduction of new products, equipment, or processes. Drive operational readiness for new product introductions and major capital or modernization projects. Manage and execute change controls within the manufacturing organization. Participate in equipment start-up, commissioning, qualification, and validation. Drive continuous improvement using Lean/Six Sigma principles to enhance efficiency, reliability, compliance, and reduce operational variability while delivering measurable performance gains. Develop and track operational KPIs; communicate performance to management. Deliver training and coaching to manufacturing staff and SMEs across assigned functional areas. Ensure adherence to all regulatory standards, internal policies, and safety expectations. Support internal audits, external inspections, and readiness activities. Responsible for managing and enforcing finite scheduling and schedule adherence across projects, implementations, and clinical/commercial manufacturing activities. Here's What You'll Need (Basic Qualifications) Education: Bachelor's degree in Engineering, Life Sciences, or a related field. Advanced degree preferred. Experience : 5-8 years of experience in biopharmaceutical manufacturing operations, or a Master's degree with 2-5 years of industry experience. Experience with deviation/investigation management systems and technical writing in a cGMP environment. Experience with buffer prep, formulation, aseptic manufacturing operations, isolator technology, media fills, automated visual inspection, automated labeling & packaging, or serialization preferred. This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work. 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. Here's What You'll Bring to the Table (Preferred Qualifications) Proficiency in Lean manufacturing methodologies and Six Sigma principles. Proficient in digital systems such as SAP, MES, and electronic batch records. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between. Best-in-class healthcare coverage, 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 investment opportunities 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 compens

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