GMP Drug Substance Associate I – Precision & Execution

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

Benefits offered by this job

Healthcare benefits

Well-being resources

Family planning benefits

Generous paid time off

Savings and investments

Job summary

Moderna in the United States is seeking a Manufacturing Associate I in Drug Substance Operations to help produce mRNA drug substance in a tightly controlled GMP environment. This hands-on role rewards precision, continuous learning, and a team‑driven mindset.

You will execute manufacturing operations, perform cleanroom tasks, document in real time, maintain readiness of the production area, and collaborate with cross‑functional partners to ensure quality and compliant execution.

Qualifications

• Bachelor’s degree in a STEM field with 0-1 years of relevant industry experience, 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.
• Strong attention to detail
• A disciplined and consistent approach to execution
• The ability to stay focused in a structured environment
• A team-first mindset and willingness to support shared goals
• The ability to learn technical processes and apply them reliably
• Good judgment, professionalism, and accountability
• Comfort working in a cleanroom environment and following defined procedures closely
• A mindset of continuous improvement and a willingness to keep raising the bar
• The confidence to speak up early, elevate issues appropriately, and help maintain a strong quality and compliance culture

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

Discipline

Teamwork

Learning agility

Judgment

Communication

Cleanroom discipline

Education

Bachelor's degree in STEM

Associate's degree

High school diploma

Tools

SAP

Veeva

DeltaV

Syncade

LIMS

CMMS

Job description

Moderna in the United States is seeking a Manufacturing Associate I in Drug Substance Operations to help produce mRNA drug substance in a tightly controlled GMP environment. This hands-on role rewards precision, continuous learning, and a team‑driven mindset.

You will execute manufacturing operations, perform cleanroom tasks, document in real time, maintain readiness of the production area, and collaborate with cross‑functional partners to ensure quality and compliant execution.