Senior Research Associate - Viral Vector Analytics

Senior Research Associate - Viral Vector Analytics

Founded at the birthplace of biotechnology, Nkarta's mission is to discover, develop and deliver novel off-the-shelf (e.g. allogeneic) natural killer (NK) cell therapies that profoundly impact patients' outcomes and survival . The company is based on the proprietary, robust and well-characterized NK cell expansion technology pioneered by Dr. Dario Campana. Nkarta is focused on leveraging the inherent power of NK cells to identify and kill abnormal cells and recruit adaptive immune effectors to generate responses that are deep and durable.

Nkarta combines its NK cell expansion and cryopreservation platform with proprietary cell engineering technologies to generate an abundant supply of NK cells, engineer enhanced NK cell recognition of tumor targets, and improve persistence for sustained activity in the body for the treatment of cancer.

Founded in 2015, Nkarta became a public company ( Nasdaq symbol NKTX ) in 2020. Our development pipeline of engineered NK cell therapy candidates consists of two 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. We expect to begin dosing patients in this study by the end of 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. In addition, we recently completed the construction of a GMP compliant clinical manufacturing facility in our South San Francisco location designed to produce viral vector and supply our initial clinical trials.

Position Title Senior Research Associate - Viral Vector Analytics

Location South San Francisco

Reports to Senior Scientist, Analytical Development

Position Summary

This role adds to the build out and development of our growing Vector Analytics group within the Analytical Development team. The Senior Research Associate will work closely with Viral Vector Process Development and QC groups to develop, optimize, and perform analytical methods for viral vector characterization and release testing for Nkarta's viral vector platforms.

Key Responsibilities

• Participates /collaborates in the successful development, execution, analysis, and documentation of analytical methods for the characterization (safety, identity, strength/potency, purity, quality), release, and stability monitoring of development and clinical retrovirus-based viral vectors.

• Performs analytical method technical transfer to Quality Control (QC), Contract Testing Laboratories (CTL), and Contract Manufacturing Organizations (CMO).

• Creates, compiles, and reviews technical and regulatory documents, including, but not limited to, analytical study data summaries and reports, analytical method development reports, method qualification/validation protocols and reports, and standard operating procedures in compliance with regulatory requirements.

• Troubleshoots, optimizes, and conducts trending of analytical assay performance.

• Participates in and/or performs analytical assays as may be assigned.

Position Requirements

• In-depth knowledge of and experience with the development and execution of viral vector characterization assays.

• Extensive hands-on experience and technical expertise with the following assays:

o Viral titer assays (qPCR, flow cytometry)

o Viral particle measurement (qPCR, ELISA)

o Residual Host Cell DNA/plasmid assays (qPCR, Southern Blot)

o Impurity assays for viral lots (HCP, BSA, nuclease, etc. by qPCR or ELISA)

• The ideal candidate must be detail-oriented, independently motivated, and has strong problem-solving and troubleshooting skills.

• Ability to multitask, prioritize, effectively collaborate in a team setting, and meet deadlines in a fast-paced environment.

• Proficiency in MS Office, JMP, GraphPad, Softmax Pro, and FlowJo, or equivalent.

• Excellent verbal and writing skills for documentation of data, drafting of technical reports, and communication of progress to supervisor and project teams.

• Embodies the company culture of empowerment, diversity, and inclusion.

Preferred

• Strong background in immunology with knowledge of NK and T cell biology, and hand-on experience with primary NK or T cells.

• Experience with analytical method qualification and technical transfer.

• Understanding of and experience with ICH and FDA cell and gene therapy regulations and guidance.

Education / Background

• BA/BS in biology-related discipline and 3-6+ years of laboratory experience, MS in biology-related discipline with 2-4+ years related laboratory experience, with preference for candidates with viral vector, immunology, and industry experience.

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 any laboratory environment.

About Nkarta

The 70+ team members at our South San Francisco, California headquartered location describe working at Nkarta, along with opportunities for improvement, in some of the following ways:

"Work is interesting - lots of projects in the pipeline (so I don't have to worry about the one project failing). Leadership is open, straight forward."

"Smart, capable, nice people. People I work with day to day are enjoyable."

"Employee-centric."

"Like any startup there are fires to put out; we feel confident we have the people to control those fires."

"Diverse people from different backgrounds."

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