Senior Process Engineer, Drug Substance & LNP

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

Benefits offered by this job

Competitive healthcare

Well-being resources

Fertility/adoption support

Generous PTO & sabbatical

Location-specific perks

Job summary

Moderna is seeking a highly experienced process engineering SME to support Drug Substance technologies across its global manufacturing network. You will help design, scale, and optimize IVT, chromatography, TFF, and LNP processes, ensuring robust, compliant, and scalable solutions for clinical and commercial production.

You will collaborate with R&D, MS&T, and Manufacturing, develop key process documents, and drive continuous improvement while mentoring junior engineers and upholding Moderna’s

Qualifications

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or related field; Master’s preferred.
• 7–10 years in process engineering/manufacturing science in biopharma/biotech/sterile manufacturing.
• Hands-on Drug Substance processes (IVT, chromatography, TFF, LNP) experience.
• Experience supporting process design and equipment specification in regulated manufacturing.
• Experience with process simulation, mass/energy balances, scale-up modeling.

Responsibilities

• Serve as technical SME for Drug Substance processes (IVT, Chromatography, TFF, LNP).
• Design, scale-up, and implement modular process skids aligned with GxP and Moderna standards.
• Develop PFDs, P&IDs, URS, and FRS for Drug Substance systems.
• Contribute to CIP design and optimization focusing on safety and reliability.
• Collaborate with stakeholders and vendors to meet performance and quality goals.
• Support investigations, deviations, and continuous improvement.
• Participate in technical reviews and standardization under Technical Authority governance.
• Ensure compliance with GxP/GMP and Moderna quality systems.
• Maintain training/docs and audit readiness.
• Mentor junior engineers and drive engineering excellence.

Skills

IVT

Chromatography

TFF

LNP formulation

Process simulation & modeling

Automation & PAT

Cross-functional projects

Regulatory knowledge (GxP/GMP)

Data integrity & quality

Education

Bachelor's degree in Chemical/Biochemical Engineering

Master's degree preferred

Tools

Process simulators

GxP software

Job description

Moderna is seeking a highly experienced process engineering SME to support Drug Substance technologies across its global manufacturing network. You will help design, scale, and optimize IVT, chromatography, TFF, and LNP processes, ensuring robust, compliant, and scalable solutions for clinical and commercial production.

You will collaborate with R&D, MS&T, and Manufacturing, develop key process documents, and drive continuous improvement while mentoring junior engineers and upholding Moderna’s