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Senior Research Associate/Research Associate, Analytical Development

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Website Nkarta, Inc.

Nkarta, Inc.

Company : Nkarta, Inc.

Country: United States

Location : South San Francisco, California

Post: Sat, 30 Jul 2022 21:07:21 GMT

Expires: Sat, 27 Aug 2022 23:59:59 GMT

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—————————— Job Description ——————————

About Us:
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.

 

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 need.

Overview:
We are seeking a highly motivated and highly collaborative Research Associate/Senior Research Associate to join the Viral Vector, Analytical Development (AD) team in implementing various assays to characterize and release testing for Nkarta’s viral vector platforms. The Research Associate/Senior Research Associate will work closely with Viral Vector Process Development and QC groups using analytical capability to continue support for Nkarta’s NK products.

Responsibilities:
Collect data from analytical assays and perform data analysis, including troubleshooting and conduct trending of analytical performance.

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.

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 (SOPs) in compliance with regulatory requirements.

Maintain accurate and complete records for all results

Maintain stock of critical reagents and provide general lab support

Support analytical assay development, using flow cytometry, ELISA, qPCR/ddPCR, etc.

Present results at team and company meetings

Qualifications:
Hands-on experience and technical expertise with the following assays:Viral titer assays (qPCR, ddPCR, flow cytometry)

Viral particle measurement (qPCR, ELISA)

Impurity assays for viral lots (Host Cell Protein, Residual BSA, nuclease, etc by either qPCR or ELISA)   

Ability to work independently, multitask, and meet deadlines in a fast-paced environment.

Highly motivated, organized, and disciplined record keeping; strong attention to detail.

Excellent verbal and written communication skills.

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

Basic to in-depth knowledge of developing and executing viral vector characterization assays.

Embodies the Nkarta culture of empowerment, diversity, and inclusion.

Preferred:

Experience in droplet digital PCR (ddPCR), qPCR

Experience in cell culture (both primary and cell lines)

Strong knowledge and understanding of analytical method qualifications and technical transfer.

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

Familiarity with Quality Control or regulated environments

 

Education / Background

Bachelors or MS degree in Molecular Biology, Immunology, Cell Biology, or related field

Two or more years relevant experience in biopharmaceutical or biotechnology industry is a plus.

1+ years industry Analytical Development experience is preferred.

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.

Working at Nkarta Inc.:
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 

 

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