Senior Scientist, Process Development - Downstream

Rocket Pharmaceuticals•Cranbury, NJ

1d•$126,000 - $152,000

About The Position

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. Position Summary The Process Development function is seeking a highly motivated downstream process development Senior Scientist to support development of viral vector manufacturing processes. At Rocket Pharmaceuticals, 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 Process Development 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.

Requirements

PhD/MS in chemical engineering, biochemical engineering, bioengineering, biochemistry, biological sciences, or relevant field of study
PhD with 2+ years or MS with 8+ years of hands-on experience in process development, MS&T, or manufacturing in Biotech/biopharmaceutical industry. Experience with gene therapy a plus.
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.
Excellent communication and presentation skills, capable of conveying complex technical information in a clear, thorough, and influential manner is required.
Eager to work with highly skilled and dynamic teams in a fast-paced, 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.
Experience with statistical analysis tools (e.g., JMP, Minitab) is required.

Nice To Haves

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 and/or process characterization and/or process performance qualification and validation is desirable.

Responsibilities

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 with process development and analytical development teams

Benefits

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

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