Quality Assurance Specialist II

Nkarta is a publicly traded (Nasdaq symbol NKTX), biotechnology company headquartered in South San Francisco focused on the discovery, development and manufacturing of off-the-shelf, natural killer (NK) cell therapies. Our near-term goal is to bring cell therapy out into the community setting, dramatically expanding access for patients. 

Founded in 2015 at the birthplace of biotechnology, Nkarta is a fast-growing, fast-moving, clinical-stage company that has built an extensive cell therapy manufacturing operation in anticipation of product commercialization. Our developmental pipeline of engineered NK cell therapies includes clinical programs in B-cell malignancies and autoimmune diseases.

Complementing our broad research and development capabilities, Nkarta has also built an extensive cell therapy manufacturing operation.  We recently built out a 23,000-square foot clinical good manufacturing practice, or cGMP, facility on-site at our primary corporate location in South San Francisco, California.

Nkarta is a people-driven company looking for passionate, collaborative, driven team members galvanized by a paradigm-shifting opportunity to change the cell therapy landscape.  

Nkarta offers 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.

• Supports activities for releasing or rejecting raw materials, starting materials, intermediates, drug substance, and drug products.
• Reviews completed batch production and laboratory control records of critical process steps before disposition of drug product for clinical 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, drug product AQL inspection, and line clearance. Assists on changes that potentially impact intermediate, drug substance, and/or 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 events.
• Participates in cross-functional collaborations to meet project timelines and material/product supply requirements
• Act as the Quality Lead between Nkarta and Nkarta’s Contract Manufacturing Organizations (CMO) sites for packaging and labelling of clinical drug product. This includes being the liaison in managing and addressing queries, concerns, and requests between Nkarta and the CMO.

• • In depth knowledge of GMP regulations and compliance.
  • Previous experience with GMP manufacturing of cell therapy or biological products.
  • Robust understanding and knowledge of quality assurance concepts, investigations, and process improvements.
  • Excellent communication skills, both written and verbal
  • Strong organization skills and ability to effectively manage multiple priorities.
  • Ability to set and achieve goals to develop professionally.
  • Ability to work independently and solve problems creatively.
  • Comfortable working in the fluid structure of a start-up biotech company.
  • 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.

   

  Education / Background

  • Bachelors degree in Biology, Chemistry, Life Science or equivalent.
  • 5+ years of biopharmaceutical industry experience.

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. Able to fully gown into GMP cleanroom suites that include Grade B to provide on the floor QA support for manufacturing activities.

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 required of this role for conferences and meetings. This role is local to the office in South San Francisco.

A reasonable estimate of the current salary range for this position is $113,000 - $125,000.  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 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 150+ 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 on which we are working, here are real, anonymous comments about or regarding 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.