Senior Process Engineer, MS&T

Position Summary

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.

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.

Qualifications

• PhD with 2 years, MS with 6 years, or BS with 8 years of late stage and commercial drug development experience.
• Gene therapy experience is preferred.
• 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

Compensation

The expected salary range for this position is $118,000 to $158,000. At Rocket, our compensation philosophy and ranges are built upon data and insights collected from validated world-class providers. We are committed to compensating employees equitably based on several factors, including responsibilities and level of the position, depth and types of the employee's experience, location of the position and availability of similar talent in a competitive market. For U.S.-based candidates, this is an at-will position, and Rocket reserves the right to adjust the range at hire or during the year due to market shifts.

In addition to base salary, Rocket offers a competitive total rewards package that may include bonuses (short-term incentives), medical, dental, and vision insurance, life insurance, 401(k) with company match and generous vesting, paid vacation and holidays, global shutdown days between Christmas and New Year's, and a variety of wellness resources and employee support programs. Also, certain positions are eligible for added forms of compensation, such equity awards (long-term incentives).