Nkarta is a publicly traded (Nasdaq symbol NKTX), South San Francisco headquartered, clinical-stage biotechnology company advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies for cancer patients. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies and CRISPR-based genome engineering capabilities, Nkarta is building a pipeline of future cell therapies engineered for deep anti-tumor activity and intended for broad access in the outpatient treatment setting.

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 NKX101 NKX019 are in process. 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 manufacturing facility on-site at our primary corporate location in South San Francisco, California. In-house manufacturing of NKX019 commenced in 2021, and NKX101 in-house manufacturing is planned to begin in 2022. We are also currently designing a separate, larger cGMP facility, to supply our anticipated pivotal clinical trial and commercial needs.

Nkarta offers a unique opportunity for a highly-motivated Director of Validation to join our growing Quality Assurance team.  This role is responsible for developing the qualification strategy for Nkarta. The role has responsibility and oversight of the qualification and commissioning activities for the current manufacturing facility, including but not limited to equipment and facility, as well as the qualification of our new manufacturing suite and the eventual process qualification. It is a key position that will closely coordinate with internal and external partners in a cross-disciplinary team of Process Development, Manufacturing, Quality, and Facilities to develop and implement best practices in qualification and validation at Nkarta.

• Develop and implement a compliant, phase-appropriate validation strategy.
• Manage all operational validation activities.
• Work closely with all departments to ensure the operation of a validated environment according to GMP and other regulatory requirements.
• Qualify the equipment and facility used in the manufacture, testing, and storage of raw materials, drug substance, and drug product.
• Maintain the equipment used for qualifying the equipment and facility.
• Write and execute protocols to qualify the equipment and facility.
• Investigate and resolve qualification-related deviations.
• Participates in cross-functional collaborations to meet project timelines and material supply requirements.
• Maintain the Validation Master Plan and Elemental Validation Plans (including but not limited to Computer Systems, Equipment, Utility/Facility, Cleaning, Quality Control).
• Scheduling, planning, and reviewing validation activities.
• Oversight of CDMO (contract development and manufacturing organization) qualifications.
• Other duties as assigned.

• Previous experience working with equipment, cleaning, facility, utility, computerized systems, and/or environmental monitoring 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 computer system validation and data integrity.
• Experience with cell therapy production processes and viral transduction principles and processes.

Education / Background

• Bachelors degree in Biology, Chemistry, Life Science.
• +10 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.

A reasonable estimate of the current salary range for this position is $215,000 - $280,000.  There are several factors taken into consideration in determining base salary, including but not limited to: job-related qualifications, skills, education and experience, as well as job location and the value of other elements of an employee’s total compensation package.  Nkarta also offers an annual discretionary bonus, equity grant(s), medical, dental, vision and life insurance coverage, in accordance with the terms and conditions of the applicable plans.  Other benefits include 401K plan, flexible spending account, ESPP, employee assistance program, paid vacation, holiday and personal days, paid parental, pregnancy, and bereavement leave. 

The 160+ 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