Quality Assurance Specialist

Quality Assurance Specialist

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 QA Specialist

Location South San Francisco, CA

Reports to Sr. Manager, Quality Assurance

Position Summary

Nkarta is offering a unique opportunity for a highly-motivated QA Specialist to join our growing Quality Assurance team. This role supports the qualification of our new manufacturing site and technical transfer of advanced NK cell therapies. It's also 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.

Key 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.

• Assists in the investigation and resolution of quality related complaints

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

Position Requirements

• 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.

• Willingness and ability to travel up to 10%.

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

Preferred

• Experience working with CMOs.

• 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

The 70+ team members at our South San Francisco, California primary 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."
• "I like that the company is open minded with a (people) -(looking for) a set of skills that can grow (as opposed to thinking you have to have exactly what's in a job spec now) Things that broaden their (employees) skills and growth."
• "Like any startup there are fires to put out; 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