Onsite GMP Drug Substance Manufacturing Associate

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

Benefits offered by this job

Healthcare benefits

Well-being resources

Family planning support

Generous paid time off

Savings and investments

Location-specific perks

Job summary

Moderna seeks a Manufacturing Associate I in Drug Substance Operations to produce mRNA drug substance in a tightly regulated GMP setting. The role emphasizes precision, accountability, and teamwork, with a hands-on, operations-focused environment and real-time documentation.

The position requires learning quickly, staying curious, and applying disciplined execution to aseptic processing, formulation, and related tasks. It is 100% onsite, with strong emphasis on safety and quality.

Qualifications

• Bachelor’s degree in a STEM field with 0-1 years or an Associate’s with 2-4 years or a high school diploma with >4 years of relevant experience.
• Experience in manufacturing, operations, biopharma, or regulated environments is helpful; interest in a digital-forward biomanufacturing environment is important.

Responsibilities

• Execute manufacturing operations following approved procedures and batch records in a GMP environment.
• Perform cleanroom operations with detail and consistency.
• Support drug substance manufacturing activities including aseptic processing, formulation, filtration, mixing, filling, and dispensing.
• Work within the human performance model for error prevention and accurate execution.
• Complete documentation in real time with good data integrity.
• Maintain cleanliness, control, and readiness of the production area.
• Use systems and equipment such as SAP, Veeva, DeltaV, Syncade, LIMS, and CMMS as required.
• Develop understanding of equipment, process flow, and digital systems to recognize issues and apply technical judgment.
• Follow safety, waste handling, and environmental guidelines.
• Complete required training and maintain gowning and operation qualifications.
• Collaborate with teammates and cross-functional partners, communicating clearly and elevating issues early.

Skills

Attention to detail

Disciplined execution

Focus in structured environment

Team orientation

Learn technical processes

Judgment and accountability

Cleanroom experience

Quality and compliance culture

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 seeks a Manufacturing Associate I in Drug Substance Operations to produce mRNA drug substance in a tightly regulated GMP setting. The role emphasizes precision, accountability, and teamwork, with a hands-on, operations-focused environment and real-time documentation.

The position requires learning quickly, staying curious, and applying disciplined execution to aseptic processing, formulation, and related tasks. It is 100% onsite, with strong emphasis on safety and quality.