Senior MS&T Process Engineer - Gene Therapy Manufacturing

Rocket Pharmaceuticals; Cranbury Township (NJ); On-site; USD 118,000 - 158,000; Full time

Job summary

Rocket Pharmaceuticals in the United States is seeking a Senior Process Engineer in the Manufacturing Science & Technology (MS&T) group to drive early and late-stage AAV development, technology transfer, and lifecycle management. The role emphasizes process validation, CPV/APQR activities, and cross-functional collaboration to enable scalable GMP production of drug substance and product.

The ideal candidate has a strong background in viral vector or biologics manufacturing with a track record in

Qualifications

• PhD/MS/BS with required years of late-stage and commercial drug development experience.
• Proven ability to work in a fast-paced, self-driven environment.
• Proven track-record for late-stage clinical manufacturing support and process validation execution and authoring CTD sections.

Responsibilities

• Support CPV, APQR, process monitoring, and lifecycle process validation activities.
• Own deviations, investigations, change controls, technical assessments, and quality system deliverables.
• Support GMP manufacturing operations including planned runs and Process Improvement Program initiatives.
• Develop validation documentation for PPQ program planned for 2027, including PPQ protocols and validation Master Plans.
• Lead root cause investigations and product impact assessments for critical quality events.
• Collaborate with Manufacturing, Process Development, Quality Control and QA to resolve technical issues and drive improvements.
• Author and review MS&T documents including protocols, reports, risk assessments, and Module 3 sections for IND and BLA submissions.

Skills

GMP manufacturing

Process validation

Excellent communication skills

CTD/IND/BLA documentation

Education

PhD with 2 years, MS with 6 years, or BS with 8 years of late stage and commercial drug development experience

Tools

CTD/IND submissions

Job description

Rocket Pharmaceuticals in the United States is seeking a Senior Process Engineer in the Manufacturing Science & Technology (MS&T) group to drive early and late-stage AAV development, technology transfer, and lifecycle management. The role emphasizes process validation, CPV/APQR activities, and cross-functional collaboration to enable scalable GMP production of drug substance and product.

The ideal candidate has a strong background in viral vector or biologics manufacturing with a track record in