Senior Process Engineer, Drug Substance & LNP

Moderna Therapeutics; Norwood (MA); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

Healthcare

Well-being programs

Fertility/adoption/surrogacy support

Generous paid time off

Savings and investments

Location-specific perks

Job summary

Moderna is seeking a Global Engineering Technical Authority SME to provide advanced technical expertise across Drug Substance process technologies, ensuring designs are robust, compliant, and scalable for commercial and clinical production of mRNA and LNP platforms.

You will collaborate with R&D, MS&T, and Manufacturing to apply standardized design practices and deliver innovative solutions aligned with Moderna’s engineering standards, while mentoring junior engineers and driving continuous

Qualifications

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or related field.
• Master’s degree preferred.
• 7–10 years of process engineering or manufacturing science experience in biopharmaceutical, biotech, or sterile manufacturing.
• Hands‑on experience with Drug Substance processes such as IVT, chromatography, TFF, and LNP systems.
• Proven ability to support process design and equipment specification in a regulated manufacturing setting.
• Demonstrated experience in process simulation and modeling to support design, capacity analysis, and technology transfer.

Responsibilities

• Serve as a technical SME for Drug Substance processes (IVT, chromatography, TFF, LNP).
• Design, scale-up, and implement modular small-scale process skids meeting GxP requirements.
• Develop PFDs, P&IDs, URS, and FRS for Drug Substance manufacturing systems.
• Contribute to CIP system design and optimization for safety, efficiency, and reliability.
• Collaborate with stakeholders and vendors to ensure equipment specs and automation meet objectives.
• Support root cause investigations, deviations, and CI projects to improve performance.
• Contribute to technical reviews, design evaluations, and standardization under Technical Authority governance.
• Ensure compliance with GxP/GMP and Moderna quality systems.
• Maintain training, documentation, and audit readiness.
• Mentor junior engineers and drive continuous improvement.

Skills

IVT processes

Chromatography

TFF (Tangential Flow Filtration)

LNP formulation

GxP compliance

Education

Bachelor's degree in Chemical/Biochemical Engineering

Master's degree preferred

Job description

Moderna is seeking a Global Engineering Technical Authority SME to provide advanced technical expertise across Drug Substance process technologies, ensuring designs are robust, compliant, and scalable for commercial and clinical production of mRNA and LNP platforms.

You will collaborate with R&D, MS&T, and Manufacturing to apply standardized design practices and deliver innovative solutions aligned with Moderna’s engineering standards, while mentoring junior engineers and driving continuous