Senior Process Engineer, MS&T

Create a future where DNA is no longer destiny.

Join Rocket Pharma.

Rocket Pharma is a fully integrated, late-stage biotechnology company advancing gene therapies with curative potential for patients with rare and life-threatening diseases.

We are a team of creative, compassionate, and driven individuals united by a profound mission of seeking gene therapy cures.

Rocket places tremendous value on our people and fosters a collaborative environment where bold ideas thrive and every team member makes a meaningful impact.

Our core values guide everything we do: we trust one another, show generosity toward patients, embrace curiosity, and strive to elevate science.

Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits.

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.

• 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.