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Research Scientist, Upstream Process Development – Morris Plains, NJ
Gilead Sciences has an opportunity for an experienced candidate in the Upstream Process Development & Molecular Biology within the Pharma & Biologics Ops Admin department located in Morris Plains, New Jersey. The team operates with the mission to develop manufacturing processes for our company’s ADC/biologics portfolio, including cell line and upstream process development of monoclonal antibody (mAb) products. We are highly committed to employ new technologies for the development of our R&D footprint and capabilities to grow our pipelines.
This position is for a Research Scientist role, primarily dedicated to the rapid development and implementation of various innovative, robust, scalable, and high productive CHO cell culture fed-batch, intensified, and/or perfusion processes/platforms for clinical programs at different stages that have high material requirements or other technical challenges . An ideal candidate will demonstrate in-depth scientific understanding of mammalian cell biology, cell culture media, bioreactor engineering principles, product quality attribute science, along with broad, experience-based skill sets in technology transfer and scale-up.
Develop and implement new technologies/business strategies to improve process capabilities and drive operational efficiency. Drive cell culture and bioreactor development and champion creative process improvement initiatives.
Drive technology development for process intensification (e.g., using alternating tangential flow filtration technology, ATF ) and continuous manufacturing processes (that are amenable to cGMP operations) to reduce manufacturing costs and footprint.
Design and execute studies and interpret experimental results. Provide update/findings and make technical recommendations to the team/management on project related issues (e.g., study design, priorities, resources, future strategies).
Write and review SOP, technical summary, and development reports for efficient knowledge management.
Keep current in relevant literatures/patents and related new technologies with a track record of successful applications of said technologies that comply to current and emerging regulatory requirements. Contribute to a culture of innovation and an environment of technical mastery.
Author patents, peer-reviewed publications, and presentations for scientific and technological developments.
Serve as a subject-matter expert (SME), inspire trust, respect, and collaboration.
Knowledge & Skills
Good understanding of Chinese Hamster Ovaries (CHO) cell biology and metabolism, chemically-defined media, and engineering principles (mass transfer, mixing, shear, etc.) for bioreactor scale-up.
Expertise in cell culture, fed-batch process, perfusion (e.g., ATF) technology, and/or platform development in controlled bioreactors with a variety of systems including bench-scale reactors and high throughput technologies (e.g., ambr).
Excellent/strong communication and presentation skills. Proven track record of accomplishments (scientific publications and/or presentations) in upstream process, media development, or technology development areas (e.g., ATF perfusion, Raman spectroscopy).
Working knowledge of design of experiments (DOE), in-depth understanding of statistical analysis, interpretation of multivariate cell culture data using statistical software (e.g., JMP, Design Expert, MiniTab) or toolbox in Matlab, etc.
Strategic and innovative thinker with track record of fresh insightful thinking by developing creative approaches to processes/practices and implementation of new technologies.
Self-motivated individual with a “can do” attitude coupled with a willingness to do what it takes to achieve team goals and overcome whatever project obstacles occur. Strong problem-solving skills in anticipating issues, identifying root causes of critical process deviations, and recommending effective/ efficient technical solutions to the team.
Strong organizational skills and flexibility to work both independently and as a member in a matrix environment. Abilities to work strategically in a detail-oriented framework, react productively to changes in priorities, and handle other essential tasks well as assigned.
Flexibility of hours to support cell culture processes over weekends when needed. Ability to meet reasonable deadlines of tasks/projects.
Hands-on experience with perfusion (e.g., ATF, TFF) cell culture or continuous manufacturing is strongly preferred.
Strong understanding of processes, equipment, and facilities involved and extensive hands-on experience with bench-top bioreactors (e.g., applikon vessels coupled with finesse controllers) is preferred.
Hands on experience with high-throughput microreactor systems (e.g., deep-well plate assays, robotics such as ambr250, ambr15, Dasgip) is desirable.
Experience with the operation and troubleshooting of single-use bioreactor (SUB) systems and scale-up (e.g., 50L, 200L) is beneficial.
Experience with (pre-)pivotal phase process development is preferred.
Working knowledge of advanced in situ analytics for process monitoring and control using spectroscopic sensors/methods (e.g., Raman, FT-IR, NIR, in-line UV measurements) is highly desirable.
Education & Experience
PhD in Chemical Engineering, Biochemical Engineering, Bioengineering, Biotechnology, Cell Biology, Biochemistry, Chemistry, or related scientific fields/discipline or MS with 6+ years of experience, or BS and 8+years of relevant experience in the biotech or biopharmaceutical industry.
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