$100K — $150K *
Associate Director, Cell Therapy Process Engineering & Scale-up Development
Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off the shelf natural killer (NK) cell therapies for cancer. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies, Nkarta is building a pipeline of cell therapy candidates generated by efficient manufacturing processes, which are engineered to enhance tumor targeting and improve persistence for sustained activity in the body.
Founded in 2015 at the birthplace of biotechnology in South San Francisco, CA, Nkarta became a public company (Nasdaq symbol NKTX) in 2020. Our development pipeline of engineered NK cell therapy candidates consists of co-lead programs, NKX101 and NKX019. The IND for NKX101 for the treatment of relapsed or refractory AML and higher-risk MDS was accepted by the FDA in July 2020. Patient dosing began in Q4 2020. As we broaden the development of NKX101, we also plan to initiate studies in solid tumors. Our second co-lead program, NKX019, is designed to target B cell lymphomas. We plan to file our IND for NKX019 with the FDA in early 2021.
Position Title Associate Director Cell Process Engineering & Scale-up
Location South San Francisco
Reports to Sr. Director, Process Development
This role adds to the build out and further development of our growing process development team with the advancement of the production and analytics capability for Nkarta’s NK products.
· Leads and executes process development studies to enable utilization and technology transfer of scalable cell therapy processes.
· Directs optimization of processes and procedures to collaboratively create manufacturing efficiency, process robustness and reduced costs.
· Works with subject matter experts and teams on the development of critical product parameters and attributes for the characterization and release of cell therapy products.
· Participates in cross-functional collaborations to meet project timelines and material supply requirements.
· Guides and participates in the evaluation and implementation of novel process technologies.
· Supports compilation and writing of investigational new drug (IND) chemistry-manufacturing-control (CMC) sections
· Provides guidance to senior management through presentation of hypotheses, progress, and plans to project teams and governance bodies.
· Publishes or presents scientific findings in peer-reviewed journals, at conferences, and contributes to corporate collaborations
· Presents results in team meetings and delivers presentations to both small and large groups.
· Preferred experience in:
o Suspension based-bioreactor for the culture of mammalian-cell growth especially for cell therapy
o Development and technology transfer of cell therapy products
o GMP manufacturing of cell therapy or biological products.
· Ideally possesses experience in:
o Production of cell therapies
o Viral transduction principles and processes
· Thorough understanding of Design of Experiment (DOE) and Quality by Design (QBD).
· Highly organized, detail-oriented individual with strong problem-solving skills.
· Excellent verbal and writing skills for documentation of data, drafting of technical reports, and communication of progress to supervisor and project teams.
· Must be able to communicate and multi-task within a fast-paced, highly collaborative team environment with a high degree of self-motivation and organization
· Embodies the company culture of empowerment, diversity, and inclusion.
· Ability to travel up to 10%
Education / Background
· Ph.D. in Bioengineering, Biomedical Engineering, Process Engineering and 5-6+ years of biopharmaceutical industry experience in a development setting. The ideal candidate will have at least 3-4 years of biopharmaceutical industry experience in a development setting
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