Position Summary

Rocket is seeking a highly motivated Senior Scientist, Viral Vector Process Development - Downstream to support development of viral vector manufacturing processes.

Viral Vector Process Development (PD) is responsible for development of high productivity, scalable and robust manufacturing processes for viral vectors using quality-by-design and phase-appropriate approaches. The PD function owns process development (first-in-human and commercial), process characterization, and tech transfer objectives for the AAV pipeline. In addition to this, PD collaborates with Manufacturing Operations to support clinical manufacturing and process validation activities at our internal manufacturing site and at contract manufacturing sites.

Reporting to the Associate Director of the Downstream Process Development, the Senior Scientist will support gene therapy viral vector process development programs with a focus on downstream processes and laboratory-scale data generation capabilities. They will apply separation science fundamentals and engineering principles to develop, optimize, scale-up, and transfer the downstream manufacturing processes. Working in collaborative and matrix environment, they will innovate and establish new technologies to develop and implement process platforms for the gene therapy processes.

• Lead process development, process characterization, and scale-up activities to enable high productivity, scalable, and robust downstream processes for viral vector manufacturing.
• Develop hand-on experience and technical depth to serve as a subject-matter-expert for the downstream process development of viral vectors using chromatography (e.g., affinity, ion-exchange, multi-model) and filtration (e.g., tangential flow filtration, normal flow filtration, depth filtration) technologies.
• Lead laboratory-scale studies for commercial process development, process characterization, and GMP manufacturing deviation/trend investigations activities to deliver end-to-end work-packages (e.g., process description, control strategy, facility fit assessment).
• Design and execute laboratory studies to evaluate novel technologies to improve existing processes and establish manufacturing platforms.
• Lead scale-down model establishment and qualification activities to enable process characterization and manufacturing investigations.
• Lead protocol and technical report authoring, participate in cross-functional team discussion, and present study outcomes to stakeholders.
• Interact with external CMO/CDMOs, vendors, and partners and assist in technology transfer.
• Collaborate effectively within team and across stakeholders

• PhD in chemical engineering, biochemical engineering, bioengineering, biochemistry, biological sciences, or relevant field of study with 2+ years or MS with 6+ years of hands-on experience in process development, MS&T, or manufacturing in Biotech/biopharmaceutical industry. Experience with gene therapy a plus.
• Experience with statistical analysis tools (e.g., JMP, Minitab) is required
• Sound fundamentals and/or hands-on experience of preparative chromatography (e.g., affinity, ion-exchange, multi-model) and filtration (e.g., tangential flow filtration, normal flow filtration, depth filtration) technologies to purify biologics or viral vectors or vaccines.
• Experience with high-throughput downstream process development (e.g., Tecan, 96-well resin plate, RoboColumn system) is desirable.
• Experience with scale-down model qualification and pilot scale operations is desirable
• Proven track-record of process development, process characterization and/or process performance qualification and validation is desirable.
• Excellent communication and presentation skills, capable of conveying complex technical information in a clear, thorough, and influential manner
• Ability to thrive in a dynamic, entrepreneurial, and technical environment
• Motivated to evaluate novel technologies and develop template and process platforms to support organization growth
• Excellent MS Office skills with a specific focus on word, excel and power point applications to author technical reports and presentations

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 employee27s 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 Year27s, 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).