30+ days ago
South San Francisco, CA
Staff Scientist / AssociateDirector, Analytical Development
Nkarta is a clinical-stage biotechnology company advancingthe development of allogeneic, off the shelf natural killer (NK) cell therapiesfor cancer. By combining its cell expansion and cryopreservation platform withproprietary cell engineering technologies, Nkarta is building a pipeline ofcell therapy candidates generated by efficient manufacturing processes, whichare engineered to enhance tumor targeting and improve persistence for sustainedactivity in the body.
Founded in 2015 atthe birthplace of biotechnology in South San Francisco, CA, Nkarta became apublic company (Nasdaq symbol NKTX) in 2020. Ourdevelopment pipeline of engineered NK cell therapy candidates consists of co-leadprograms, NKX101 and NKX019. The IND for NKX101 for the treatment ofrelapsed or refractory AML and higher-risk MDS was accepted by the FDA in July2020. 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 forNKX019 with the FDA in early 2021.
Position Title Staff Scientist /Associate Director, Analytical Development
Location South San Francisco,CA
Reports to Executive Director, AnalyticalDevelopment
This role adds to the build out and further development ofour growing analytical development team (manufacturing Technical Operations) withthe advancement of the production and analytics capability for Nkarta’s NKproducts.
· Provides strategic leadershipfor analytical development to support Nkarta’s cell-based therapeutics program.
· Leads and executes implementationof selected regulated assays for in-house and contract manufacturingorganization’s (CMO) QC groups; supports specification setting, qualification,and validation of assays
· Identifies critical qualityattributes (CQA) for which controlled assays must be available for lot releaseand stability, and other attributes which require characterization assays.
· Directs implementation ofnovel cell-based and genetic analytical methods to test process intermediates,ancillary products, drug substances and drug products during processdevelopment.
· Employs quality by design(QbD) and design of experiment (DOE) approaches to method development toquickly identify robust operating regions for clinical phase-appropriate assays.
· Supports compilation andwriting of IND chemistry-manufacturing-control (CMC) sections.
· Presents scientific resultsin team and company meetings.
· Publishes or presents scientificfindings in peer-reviewed journals, and at conferences.
· Demonstrates a high level ofinitiative in troubleshooting experiments and robust data analysis
· Extensive cell-based assaydevelopment experience, flow cytometry, cytotoxicity, immune functionmeasurements, ELISA, and high-throughput screening as well as qPCR, digitalPCR, knock-out and other gene modification fidelity, assessing off-targetimpacts, and similar assays.
· Experience with viral-basedassays and viral-based cell therapys.
· In-depth knowledge of FDA,ICH and GMP guidelines, particularly gene therapy regulations.
· Experience successfully managingpeople and projects.
· Highly organized, detail-orientedindividual with strong problem-solving skills.
· Excellent verbal and writtenskills for documentation of data, drafting of technical reports, andcommunication of progress to project teams.
· Able to effectivelycommunicate and multi-task within a fast-paced, highly collaborative teamenvironment with a high degree of self-motivation and organization.
· Embodies the company cultureof empowerment, diversity, and inclusion
· PhD or equivalent inImmunology, Cell Biology, or related field.
· 6+ years of assaydevelopmentexperience in the biopharmaceutical industry experience.
This positionrequires the ability to occasionally lift and/or move up to 25 pounds. Specificvision abilities for this job include close vision, depth perception, andability to adjust focus. The common requirements of an office environment(computers, computer screens, workstations, etc.) apply when not working in oraround the laboratory environment. Car and airplane travel may be a requirementof this role; ability totravel up to 10%.
The 90+ team membersat our South San Francisco, California headquartered location describe workingat Nkarta through our most recent surveys in some of the following ways:
Strong kudos to the team and company to promote andmaintain high levels of accurate, transparent communication throughout theorganization. Team members feel they are well kept up to date and fully informed on anything of importance.
The work environment is regarded is open, collaborative,transparent and broadly diverse. All of these things are highly valued andhighly regarded. The sort of culture attracts good team members, and keeps teammembers inspired to work at Nkarta.
People at Nkarta appreciate and value their teammates;people like the folks with whom they work.
The Covid 19 pandemic has brought a higher level ofdifficulty but there are also underlying challenges; being more organized andclear about who does what, where to find resources, resources where you needthem, how we’re structuring communication, better onboarding, and seeingwhen/if it’s best to reassign roles for better efficiency.
We can do a better job of clarifying roles when they’refuzzy, shifting roles as appropriate, better defined career ladders, andmore managerial attention to develop and team member development.
To learn more about our workat Nkarta and the career opportunities that will drive us forward to servepatients, please visit the company’s website at https://www.nkartatx.com