Senior MSAT Engineer - GMP Tech Transfer & Analytics

BioSpace; Norwood (MA); On-site; USD 109,200 - 174,600; Full time

Benefits offered by this job

Healthcare coverage

Well-being resources

Parental/fertility support

Generous paid time off

Discretionary bonuses

Job summary

Moderna in Norwood, MA is seeking a highly skilled MSAT professional to support technology transfer and cGMP manufacturing across modalities. You will author change controls, review CMOs, and drive CPV monitoring while collaborating with Quality, Manufacturing, and Supply Chain to ensure compliant, scalable operations.

The role emphasizes data-driven decision making, risk assessment, and strong communication within a fast-paced, collaborative environment at Moderna's Norwood campus.

Qualifications

• BS, MS or PhD in a technical discipline related to Pharmaceutical Manufacturing; BS 7–10 yrs or MS 4–7 yrs in pharma/biotech.
• Strong GMP experience in Manufacturing Operations and/or MSAT; CMOs a plus.
• Knowledge of data management tools and statistical analysis.

Responsibilities

• Support technology transfer activities for clinical and commercial products into CMOs, ensuring scale-up and execution.
• Provide technical support for cGMP manufacturing, including tech transfer docs and risk assessments.
• Author and own Moderna-led change controls and review CMO changes for scientific rigor and clear rationale.
• Review CMO deviations and investigations; perform root cause analyses, CAPAs, and product impact assessments.
• Provide technical oversight of validation activities at CMOs, including protocol review and summary report assessment.
• Drive data review, trending, and CPV-style monitoring; establish data repositories and meaningful KPIs.
• Lead cross-functional troubleshooting and continuous improvement across processes and equipment.
• Build strong relationships with CMO teams to deliver right-first-time outcomes.
• Collaborate with Quality, Manufacturing, Technical Development, and Supply Chain to ensure alignment and execution.
• Maintain alignment across global sites with shared data and standardized solutions.
• Ensure strict GxP adherence and compliance to internal policies.
• Complete required training within timelines and maintain qualification status.

Skills

GMP experience

Data management tools

Statistical analysis

Cross-functional collaboration

Change control/documentation

Education

BS/MS/PhD in Pharmaceutical Manufacturing or related technical discipline

Tools

Statistical Software (Minitab/SAS)

Documentation tools & SOP adherence

Job description

Moderna in Norwood, MA is seeking a highly skilled MSAT professional to support technology transfer and cGMP manufacturing across modalities. You will author change controls, review CMOs, and drive CPV monitoring while collaborating with Quality, Manufacturing, and Supply Chain to ensure compliant, scalable operations.

The role emphasizes data-driven decision making, risk assessment, and strong communication within a fast-paced, collaborative environment at Moderna's Norwood campus.