Specialist, Manufacturing

Moderna • Norwood, MA

1d • $74,000 - $118,400 • Onsite

About The Position

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.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 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.
• Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.
• This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law.
• Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position.

Nice To Haves

• Advanced degree preferred.
• Proficiency in Lean manufacturing methodologies and Six Sigma principles.
• Proficient in digital systems such as SAP, MES, and electronic batch records.

Responsibilities

• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level