Senior/Quality Assurance Specialist

About Us

 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.

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.

Overview

Nkarta offers a unique opportunity for a highly-motivated QA Specialist to join our growing Quality Assurance team.  This role supports the batch disposition activities for Nkarta NKX101 and NKX019 programs, including but not limited to batch records review, deviation and change control approval. The role also supports the qualification of our new manufacturing suite and technical transfer of advanced NK cell therapies. It is a key position to closely coordinate with internal and external partners in a cross-disciplinary team of immunologists, engineers, and clinicians to develop and implement best practices in cell therapy manufacturing.

Responsibilities

• Supports activities for releasing or rejecting intermediates, API, drug substance, and drug products.


• Reviews completed batch production and laboratory control records of critical process steps before release of the product for distribution.


• Reviews of Quality Control analysis and results to support product release.


• Releases or rejects raw materials, intermediates, packaging and labelling materials.


• Conducts Quality on the Floor activities including, but not limited to, quality walk-throughs, change-over and line clearance. Assists on changes that potentially impact intermediate or API, drug substance, and drug product quality.


• Review and or approve validation deliverables/documentation during the validation process (e.g., validation plans, user requirements, risk assessments, installation qualification, operational qualification, performance qualification and validation summary reports).


• Assists in the investigation and resolution of quality related complaints


• Participates in cross-functional collaborations to meet project timelines and material supply requirements

Qualifications

• Previous experience with GMP manufacturing of cell therapy or biological products is a plus.


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


• Independence and creative problem-solving abilities; comfort working in the fluid structure of start-up biotech.


• Integrity, confidence, passion and collaborative spirit are highly valued.


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

Preferred

• Experience with cell therapy production processes and viral transduction principles and processes.

Education / Background

• Bachelors degree in Biology, Chemistry, Life Science.


• +5 years of biopharmaceutical industry experience.

Work Environment / Physical Demands

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. Car and airplane travel might be requirement of this role.

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 www.nkartatx.com