Specialist, Manufacturing

Description

• 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.

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.