Nkarta is a publicly traded (Nasdaq symbol NKTX), South San Francisco headquartered, early-stage biopharmaceutical company focused on the discovery, development and commercialization of allogeneic, off-the-shelf engineered natural killer, or NK, cell therapies to treat cancer.


Location                     South San Francisco, CA

Reports to                  Executive Director, Analytical Development

 

Position Summary

This role adds to the build out and further development of our growing analytical development team with the advancement of the production and analytics capability for Nkarta’s NK products.  Specifically, we are seeking a highly motivated and highly collaborative Senior Scientist to design, develop and implement in-process, release and characterization assays to support Nkarta’s pipeline of viral vectors and integrated viral sequences.

 

Key Responsibilities

·       Identify critical quality attributes (CQA) for which controlled assays must be available for viral lot release and stability, and other attributes which require characterization assays

·       Select, design and implement novel viral- and cell-based analytical methods to test process intermediates, ancillary products, drug substances and drug products during process development

·       Work closely with the Viral PD group to understand their priorities for assay development

·       Manage an experienced Associate Scientist in viral AD

·       Exercise independent judgment in performing experimental methods, techniques, evaluation criteria for obtaining results, and data analysis

·       Employ quality by design (QbD) and design of experiment (DOE) approaches to method development to quickly identify robust operating regions for clinical phase-appropriate assays

·       Evaluate and transfer in appropriate research assays and improve their performance

·       Provide technical input to enhance current analytical methods

·       Write protocols and development reports, and contribute to relevant chemistry-manufacturing-control (CMC) regulatory filings

·       Tech transfer assays to in-house and contract manufacturing organization (CMO) QC groups

·       As needed, support specification setting, qualification, and validation of assays

·       Present scientific results in team and company meetings, and at scientific conferences

·       Demonstrate a high level of initiative in troubleshooting experiments and accurate data analysis

·       Participate in cross-functional collaborations to meet project timelines

·       Communicate data to senior staff and team members

Position Requirements

·       Must have extensive retroviral and/or retroviral-transduced cell-based assay development experience, particularly viral titer, RCR, viral particle measurement, detection of process-related impurities mostly by ddPCR and ELISA, and potency

·       Willing to perform lab work as well as manage that of other(s)

·       Highly organized, detail-oriented individual with strong problem-solving skills.

·       Excellent verbal and written skills for documentation of data, drafting of technical reports, and communication of progress to manager and project teams

·       Must be able to multi-task within a fast-paced, highly collaborative CMC team environment with a high degree of self-motivation and organization

·       Embodies the company culture of empowerment, diversity, and inclusion

 

Preferred

·       Familiarity with FDA, ICH and GMP guidelines, particularly gene therapy regulations and guidances

·       Experience with cell-based assays including flow cytometry, cytotoxicity, and high-throughput screening with platforms such as Cellomics CX5/CX7 or InCell 2500

·       Viral transduction principles and processes experience

 

Education / Background

A PhD or equivalent in Virology, Immunology, Cell Biology, or related field with 4+ years of assay development experience in biotech

 

Working Environment

This position requires the ability to occasionally lift and/or move up to 25 pounds. Specific vision abilities for this job include close vision, depth perception, and ability to adjust focus. The common requirements of an office environment (computers, computer screens, workstations, etc.) apply when not working in or around the laboratory environment. Willing and able to travel up to 10% via car and plane a requirement.

 

About Nkarta

Founded in 2015 at the birthplace of biotechnology, our development pipeline of engineered NK cell therapy candidates includes two co-lead clinical programs, NKX101 and NKX019. Clinical trials for 101 are in process; 019 will begin in H2 2021. Nkarta recently announced a collaboration with CRISPR Therapeutics, a world leader in gene-based medicines, for the development and commercialization of up to three new cell therapy candidates and access to clinically validated CRISPR/Cas9 genome engineering.

Complementing our broad research and development capabilities, Nkarta has also built an extensive cell therapy manufacturing operation.  We have a 2,700-square foot clinical good manufacturing practice, or cGMP, facility on-site at our primary corporate location in South San Francisco, California. We plan to start in-house manufacturing of NKX019 in 2021 and NKX101 in 2022. We are also currently designing a separate, larger cGMP facility, to supply our anticipated pivotal clinical trial and commercial needs.

 

Working at Nkarta

 

·       The 130+ team members describe working at Nkarta through some of the following comments. While getting better work-life balance and improving communications between groups in an early stage start up environment are two areas in which we’re working, here are real anonymous comments of why people think Nkarta is a great place to work.

·                     “People are always open to ideas. This company provides a safe place for its employees (covid testing, etc.)”

·                     “Exceptionally talented, committed, *kind* & supportive team”

·                     “The CEO is transparent and honest with expectations for the whole company. There is genuine care amongst the leadership team for their peers and employees. I believe this is unique.”

·                    “Not to sound corny, but the emphasis on people as a valuable resource is something I  recognize doesn't often exist elsewhere, and it's here in ample supply, which is great.”

·                     “It's the first place that I've worked where the executive team truly values the employees. It's a pretty amazing thing not to hear that employees can be replaced with someone new. Institutional knowledge is understood.”

·                     “We have a very diverse team with executives that are friendly and accessible.”

·                    “Smart and dedicated colleagues. Mission to make a difference in patients lives. Empower us with tools needed to succeed.  Open and transparent culture. Transparent leadership. Handling of covid and running the company was done very well.”

 

To learn more about our work at Nkarta and the career opportunities that will drive us forward to serve patients, please visit the company’s website at https://www.nkartatx.com