Onsite QC Bioassay Specialist – Norwood

Moderna; Norwood (MA); On-site; USD 74,000 - 118,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Family planning benefits

Generous paid time off

Savings and investments

Location-specific perks and extras

Job summary

Moderna in Norwood, MA is seeking a Quality Control Specialist to support cGMP testing of raw materials, drug substance, and finished products in our bioassay laboratory. This on-site role blends hands-on analytical testing with leadership of method transfers, qualification activities, and quality records, while collaborating with Manufacturing, QA, and Development.

You will teach analysts, write SOPs, troubleshoot methods, review data, and drive continuous improvement, aiming to ensure reliable

Qualifications

• Molecular biology experience with hands-on assay work.
• Cell-based potency assays and protein analysis experience.
• Bachelor’s degree required; STEM field preferred.

Responsibilities

• Execute testing for analytical method validation and qualification and routine testing (release, stability, in-process).
• Perform QC molecular biology and bioassay methods (qPCR, sequencing, protein analysis).
• Lead method transfers and qualification activities in collaboration with Development groups.
• Serve as SME for Bioassay; liaise with Manufacturing, QA and Development.
• Train analysts; write and revise SOPs, protocols, and reports.
• Troubleshoot methods, equipment, and procedures; review data and trends.
• Manage quality records, investigations, CAPAs, and change controls.
• Maintain safe lab environment; support audits; drive continuous improvement.
• Explore Generative AI tools for learning and knowledge sharing.

Skills

Molecular biology

Cell-based assays

Protein analysis

cGMP

Education

BA/BS degree

Tools

qPCR

Sequencing

ELISA

Job description

Moderna in Norwood, MA is seeking a Quality Control Specialist to support cGMP testing of raw materials, drug substance, and finished products in our bioassay laboratory. This on-site role blends hands-on analytical testing with leadership of method transfers, qualification activities, and quality records, while collaborating with Manufacturing, QA, and Development.

You will teach analysts, write SOPs, troubleshoot methods, review data, and drive continuous improvement, aiming to ensure reliable