Nkarta Therapeutics is a publicly traded (Nkarta NKTX symbol), 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    Director Cell Therapy Process Engineering

 

POSITION SUMMARY

The role is responsible for supporting the planning, execution, and technical support of manufacturing process scale-up and technology transfer project tasks/activities, in which ex vivo modified cell therapy drug substance and drug product operations are transferred from Process Development to Manufacturing in order to produce quality product at cGMP manufacturing scale in support of both clinical and future commercial programs


JOB DUTIES AND RESPONSIBILITIES:

·       Actively manages relationship with various internal functions including Manufacturing, Quality, and Facilities as well as manage or act as person in plant (PIP) to provide technical process development and process engineering oversight and troubleshooting of manufacturing issues as they arise.

·       Develops, leads, and performs scientific and engineering analysis for drug product handling, administration, and in-use stability studies.

·       Oversees and performs all functions associated with cell therapy process technology transfer and process monitoring and support, e.g. develop process understanding, generate bill of materials (BOM), perform gap analysis / failure mode effect and analysis (FMEA), generate process models author/review detailed process flow diagrams (DPFD), perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary reports, and perform activities for lot release (assess deviations and process changes)

·       Authors and reviews process descriptions, batch records, raw material listings, change controls independently and authors/reviews/modifies the corresponding templates

·       Supports CMC as a functional team representative and assisting in manufacturing clinical deviations and change controls.

·       Supports the development of project plans and effectively communicate progress and key deliverables to management.

·       Mentors and provide training to junior staff.

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

·       Lift up to 50Lbs

 

QUALIFICATIONS/SKILLS:

·       MS (preferred not required) in Bioengineering, Biomedical Engineering, Process Engineering and 6+ years of biopharmaceutical industry experience in a development setting or PhD degree in Bioengineering, Biomedical Engineering, Process Engineering with 4 + years of biopharmaceutical industry experience in a development setting.

·       Significant biotech industry experience supporting cell therapy process engineering, process scale up, tech-transfer, manufacturing, preferably with either ex vivo modified cells or stem cell process development or manufacturing experience

·       Experience with cell therapy manufacturing support, and experience implementing current Good Manufacturing Practices (GMP), US / EU regulations

·       Experience with flow cytometry, preferred

·       Experience with cell culture work

·       Experience with suspension bioreactors

·       Excellent communication skills, both written and oral, and high degree of organization in terms of goal setting and achieving

·       Willingness to travel up to 10%

 

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