GMP Drug Substance Operator I

Moderna; Norwood (MA); On-site; USD 54,000 - 86,000; Full time

Benefits offered by this job

Competitive healthcare

Fitness & well-being programs

Family planning benefits

Generous paid time off

Savings and investments

Location-specific perks

Job summary

Moderna is seeking a Manufacturing Associate I in Drug Substance Operations to join a GMP manufacturing team responsible for producing mRNA drug substance with precision and care.

This hands-on role requires individuals to follow approved procedures, maintain accurate documentation, and collaborate with cross-functional partners to ensure quality and patient impact. Onsite operations emphasize cleanroom discipline and a strong safety mindset.

Qualifications

• Bachelor’s degree in a STEM field with 0-1 years of relevant industry experience or Associate’s degree with 2-4 years relevant industry experience or High school diploma with more than 4 years of relevant industry experience.
• Experience in manufacturing, operations, biopharma, life sciences, or other regulated or technical environments is helpful. An interest in a structured digital-forward advanced biomanufacturing environment is important.

Responsibilities

• Execute manufacturing operations by following approved procedures, batch records, and work instructions in a GMP-regulated environment.
• Perform cleanroom operations with discipline, attention to detail, and a strong focus on consistency.
• Support drug substance manufacturing activities including aseptic processing, formulation, filtration, mixing, filling, and dispensing.
• Work within Moderna’s human performance model for error prevention, carrying out tasks with focus and accountability for accurate execution.
• Complete documentation in real time using good documentation practices and data integrity standards.
• Maintain the cleanliness, control, and readiness of the production area.
• Use manufacturing systems and equipment such as SAP, Veeva, DeltaV, Syncade, LIMS, and CMMS as required.
• Build a practical understanding of the equipment, process flow, and digital systems that support manufacturing so you can recognize issues, respond appropriately, and continue to develop and execute technical judgment.
• Follow all safety procedures, waste handling requirements, and environmental guidelines.
• Complete required training on time and maintain qualifications as needed for gowning and assigned operations.
• Work closely with teammates and cross-functional partners, communicate clearly, elevate issues early, and help support smooth execution across the operation.

Skills

Attention to detail

Team player

Execution discipline

Focused in structured environment

Learning agility

Judgment & accountability

Cleanroom work

Continuous improvement

Speak up early

Education

Bachelor’s degree in STEM

Associate’s degree (2–4 years)

High school diploma (4+ years)

Tools

SAP

Veeva

DeltaV

Syncade

LIMS

CMMS

Job description

Moderna is seeking a Manufacturing Associate I in Drug Substance Operations to join a GMP manufacturing team responsible for producing mRNA drug substance with precision and care.

This hands-on role requires individuals to follow approved procedures, maintain accurate documentation, and collaborate with cross-functional partners to ensure quality and patient impact. Onsite operations emphasize cleanroom discipline and a strong safety mindset.