Senior Process Engineer, MS&T

OverviewCreate 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.Position SummaryThe 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.ResponsibilitiesSupport 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.QualificationsPhD 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 environmentProven track-record for late-stage clinical manufacturing support and process validation execution and authoring related CTD sectionsDemonstrated 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 milestonesExperience with cGMP, ICH guidelines, process validation, and control strategy development.Excellent verbal and written communication skillsCompensationThe 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).EEO StatementA diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.Job SummaryCategory: Process DevelopmentPosition Type: Regular Full-Time