Specialist, DNA Manufacturing Support

Here's What You'll Do

• Support DNA operations directly on the manufacturing floor, providing hands-on assistance, gathering and communicating process information, escalating emerging issues, and helping ensure plasmid fermentation and purification activities are executed safely, efficiently, and in compliance with GMP requirements.
• Facilitate cross-functional meetings across Manufacturing, MS&T, Quality, Facilities, Digital, Supply Chain, and other partner functions.
• Communicate complex technical and operational information clearly and influence senior stakeholders to build alignment around high-impact manufacturing initiatives.
• Draft and revise assigned GMP documentation, including batch records, standard operating procedures, electronic work instructions, forms, and job aids, ensuring changes progress through the appropriate review and approval processes.
• Support investigations, change controls, and CAPAs by gathering relevant manufacturing and process information, obtaining stakeholder input, drafting implementation details, completing assigned actions, and tracking deliverables through closure in accordance with established quality-system requirements.
• Complete required training within established timelines and, as assigned, support the training of colleagues on revised documentation, routine manufacturing practices, and updated ways of working.
• Participate in Lean, Six Sigma, and broader process-improvement activities focused on advancing safety, quality, compliance, cycle time, yield, and cost performance.
• Take ownership of discrete actions and deliverables within larger continuous-improvement initiatives.
• Support technology transfer and manufacturing readiness activities, including bill of material readiness, equipment start-up, commissioning, validation, and other assigned Manufacturing support activities required to prepare processes and equipment for GMP execution.
• Partner across Manufacturing, MS&T, Quality, Facilities, Digital, Supply Chain, and other site functions to troubleshoot and resolve routine operational issues and ensure assigned manufacturing and technical deliverables are completed on time and to the expected standard.
• Support audit and inspection readiness by maintaining complete and accurate GMP documentation, completing assigned readiness actions, gathering requested information, and providing that information through appropriate channels.
• Represent Manufacturing during internal audits and health-authority inspections, helping provide clear, accurate, and appropriately documented information regarding manufacturing processes, practices, and execution.
• Consistently follow site expectations for safety, GMP, gowning, documentation, and data integrity, promptly escalating any safety, quality, operational, or compliance concerns through the appropriate channels.
• Apply working knowledge of GMP manufacturing processes, documentation requirements, quality systems, and bioprocess equipment to support reliable day-to-day operations while completing assigned work with quality, accuracy, and timeliness and contributing to broader team objectives within established procedures and guidance.
• Look for opportunities to use Moderna's digital capabilities and gain exposure to Generative AI-enabled tools where appropriate, helping simplify information workflows, accelerate learning, and support more efficient manufacturing execution while maintaining applicable GMP, quality, and data-integrity requirements.

Here's What You'll Need (Basic Qualifications)

• B.S. in Chemical/Biochemical Engineering, Biotechnology, or related science and 1-3 years' experience in biotechnology cGMP manufacturing/quality/development (or M.S. and 0-2 years).
• In-depth knowledge of FDA, EMA, and ICH cGMP guidelines.
• Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.