Senior Process Engineer, MS&T

Rocket Pharmaceuticals•Cranbury, NJ

About The Position

The Manufacturing Science & Technology (MS&T) function is seeking a highly motivated Senior Process Engineer to be responsible for early and late stage AAV development, commercialization, and lifecycle management. Reporting to the Associate Director, MS&T, the successful candidate will be responsible for technology transfer, process improvement implementation, process validation and technical support of late phase and commercial GMP manufacturing activities for drug substance and drug product. The ideal applicant will have a strong background in manufacturing and validation of viral vector or biologics. The incumbent will collaborate with cross-functional department colleagues within Rocket Pharma as well as external partners to ensure the successful execution of GMP production.

Requirements

PhD with 2 years, MS with 6 years, or BS with 8 years of late stage and commercial drug development experience.
Demonstrated ability to work in a self-driven, performance results/performance-oriented, fast paced environment
Proven track-record for late-stage clinical manufacturing support and process validation execution and authoring related CTD sections
Demonstrated ability to perform and document complex manufacturing process.
Motivated to drive and own functional initiatives and influence peers and stakeholders to collaborate and accomplish key milestones
Experience with cGMP, ICH guidelines, process validation, and control strategy development.
Excellent verbal and written communication skills

Nice To Haves

Gene therapy experience is preferred.

Responsibilities

Support commercial readiness activities, including Continued Process Verification (CPV), Annual Product Quality Reviews (APQR), process monitoring, and lifecycle process validation activities.
Own and execute deviations, investigations, change controls, technical assessments, and process-related quality system deliverables.
Support of ongoing GMP manufacturing operations, including planned GMP and engineering runs and Process Improvement Program (PIP) initiatives.
Develop critical validation documentation required to support the PPQ program planned for Q2 2027, including PPQ protocols, Process Validation Master Plans, microbial validation documentation, statistical analyses, and execution readiness activities.
Lead systematic root cause investigations and product impact assessments for critical quality events.
Develop strong cross-functional relationships with Manufacturing, Process Development, Quality Control and Quality Assurance to enable effective resolution to technical issues and drive continuous process improvement.
Author and review MS&T owned documents, including protocols, reports, risk assessments and Module 3 sections for IND and BLA submissions.