QC Bioassay Specialist - cGMP, Onsite in Norwood

Moderna Therapeutics; 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 PTO

Global recharge days

Job summary

Moderna Therapeutics in Norwood, MA is seeking a Quality Control Specialist to support cGMP testing of materials and products. This on-site role leads method transfers, qualification activities, and data review while collaborating with Manufacturing, QA, and Development.

A STEM degree with 5+ years in a cGMP lab is required. The role emphasizes training analysts, SOP writing, and maintaining quality records in a fast-paced biologics QC environment.

Qualifications

• STEM degree with minimum 5 years in a cGMP laboratory.
• Hands-on experience in molecular biology, cell-based assays and protein analysis.
• Method development/qualification experience with molecular biology or cell-based assays.
• Trained in aseptic techniques and general lab instrumentation (pH meters, balances, pipettes).
• Knowledge of FDA, EU, ICH guidelines and regulations.

Responsibilities

• Execute testing for analytical method validation/qualification and routine testing of release and stability samples.
• Lead method transfers and qualification activities with Development groups.
• Teach/train analysts on concepts and analytical methods.
• Write/revise SOPs, protocols, and reports ensuring cGMP compliance.
• Review data and perform analysis to understand assay performance.

Skills

Molecular biology

Cell-based assays

Protein analysis

Technical training

Analytical troubleshooting

Education

STEM degree

Tools

pH meters

Balances

Pipettes

Job description

Moderna Therapeutics in Norwood, MA is seeking a Quality Control Specialist to support cGMP testing of materials and products. This on-site role leads method transfers, qualification activities, and data review while collaborating with Manufacturing, QA, and Development.

A STEM degree with 5+ years in a cGMP lab is required. The role emphasizes training analysts, SOP writing, and maintaining quality records in a fast-paced biologics QC environment.