Senior Drug Substance Process Engineer — Scale-Up & LNP

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

Benefits offered by this job

Competitive healthcare

Well-being resources

Family planning benefits

Generous paid time off

Savings and investments

Location-specific perks

Job summary

Moderna seeks a technical SME in Global Engineering Technical Authority to advance Drug Substance processes across our manufacturing network, ensuring robust, compliant, scalable designs for commercial and clinical production of mRNA and LNP platforms.

You will collaborate with R&D, MS&T, and Manufacturing, develop PFDs/ P&IDs, support CIP, drive continuous improvement, and mentor junior engineers while maintaining compliance with GxP/GMP and our documentation standards.

Qualifications

• Bachelor’s in Chemical/Biochemical Engineering; Master’s preferred.
• 7–10 years in process engineering/manufacturing science in bio/pharma.
• Hands-on IVT, chromatography, TFF, and LNP experience.
• Experience with regulated manufacturing and equipment specification.
• Process simulation and modeling experience.

Responsibilities

• Serve as SME for Drug Substance processes (IVT, chromatography, TFF, LNP).
• Design, scale-up, and implement modular process skids per GxP.
• Develop PFDs, P&IDs, URS, and FRS for manufacturing systems.
• Contribute to CIP system design and optimization.
• Collaborate with stakeholders and vendors on specs and automation.
• Support investigations, deviations, and continuous improvement.
• Participate in technical reviews and standardization under Technical Authority.
• Ensure compliance with GxP/GMP and quality systems.
• Maintain training, documentation, and audit readiness.
• Mentor junior engineers.

Skills

Bioprocess skid design

Automation

PAT

Cross-functional leadership

Personalized medicine

GxP/GMP training

FDA/EMA/ICH knowledge

Communication skills

Problem solving

Data integrity

Education

Bachelor’s in Chemical/Biochemical Eng

Master’s degree preferred

Tools

Process simulation software

Job description

Moderna seeks a technical SME in Global Engineering Technical Authority to advance Drug Substance processes across our manufacturing network, ensuring robust, compliant, scalable designs for commercial and clinical production of mRNA and LNP platforms.

You will collaborate with R&D, MS&T, and Manufacturing, develop PFDs/ P&IDs, support CIP, drive continuous improvement, and mentor junior engineers while maintaining compliance with GxP/GMP and our documentation standards.