MSAT Engineer: GMP Tech Transfer & Validation

BioSpace; Norwood (MA); Hybrid; USD 109,000 - 175,000; Full time

Benefits offered by this job

Healthcare coverage

Well-being resources

Paid time off

Job summary

Moderna in Norwood, MA seeks a highly capable MSAT professional to advance external GMP manufacturing for multiple modalities. You will partner with CMOs, author change controls, review deviations, and drive CPV‑style monitoring with a focus on data integrity and regulatory compliance.

The role emphasizes cross‑functional collaboration with Quality, Manufacturing, Technical Development, and Supply Chain, delivering robust tech transfer and lifecycle management in a fast‑paced environment.

Qualifications

• GMP experience in Manufacturing Operations/MSAT (CMO experience is a benefit).
• Knowledge of data management tools and statistical analysis.
• Strong judgment and ability to communicate manufacturing issues in a scientifically sound and clear way, proposing data‑driven options and recommendations.
• Highly collaborative team player able to work effectively with internal stakeholders and external partners/CMOs in a cross‑functional matrix environment.

Responsibilities

• Support technology transfer activities for clinical and commercial products into CMOs, ensuring seamless scale‑up and execution
• Provide technical support for cGMP manufacturing, including authoring technology transfer documentation and risk assessments
• Author and own Moderna‑led change controls, while reviewing CMO‑owned changes to ensure scientific rigor, appropriate risk assessment, and clear implementation rationale
• Review CMO deviations and investigations, ensuring robust root cause analysis, effective CAPAs, and comprehensive product impact assessments; act as SME to challenge and guide investigations
• Provide technical oversight of validation activities at CMOs, including protocol review, execution support, and assessment of summary reports
• Drive data review, trending, and continued process verification (CPV‑style monitoring), establishing data repositories, defining meaningful KPIs, and identifying early signals or process drift
• Lead cross‑functional troubleshooting and continuous improvement initiatives across manufacturing processes and equipment
• Build strong, trust‑based relationships with CMO technical and quality teams, influencing without direct authority to deliver right‑first‑time outcomes
• Collaborate closely with internal stakeholders across Quality, Manufacturing, Technical Development, and Supply Chain to ensure alignment and execution
• Maintain alignment across global manufacturing sites through shared data, insights, challenges, and standardized solutions
• Ensure strict adherence to GxP regulations, internal policies, and compliance standards
• Execute tasks in accordance with SOPs, work instructions, and internal documentation standards
• Uphold Good Documentation Practices and Data Integrity principles to ensure inspection readiness and audit support
• Complete all required training within defined timelines and maintain qualification status

Skills

GMP experience

Technology transfer

Data analysis

Cross-functional collaboration

Validation

Quality systems

Education

B.S./M.S./Ph.D. in Pharmaceutical Manufacturing

Tools

Statistical analysis tools

Job description

Moderna in Norwood, MA seeks a highly capable MSAT professional to advance external GMP manufacturing for multiple modalities. You will partner with CMOs, author change controls, review deviations, and drive CPV‑style monitoring with a focus on data integrity and regulatory compliance.

The role emphasizes cross‑functional collaboration with Quality, Manufacturing, Technical Development, and Supply Chain, delivering robust tech transfer and lifecycle management in a fast‑paced environment.