Quality Assurance Specialist

Department: Quality
Location: South San Francisco


Nkarta Therapeutics is a private biotech startup that leverages the power of Natural Killer cells for next generation cellular immunotherapies for cancer. NK cells play a key role in the immune system, identifying and killing abnormal cells as well as recruiting the adaptive immune system. 

Nkarta is combining its NK expansion platform technology with proprietary cell engineering technologies to develop allogeneic cell therapies for the treatment of challenging diseases with significant unmet clinical need.

Nkarta is currently offering a unique opportunity for a highly-motivated QC Head to join our team with expertise in QC preferably with cell therapy experience. Initial responsibilities will include translating analytical development methods into robust processes for the testing of advanced NK cell therapies. The qualified candidate will coordinate closely with internal and external partners in a cross-disciplinary team of immunologists, engineers, and clinicians to develop and implement testing processes that embody best practices in cell therapy manufacturing.


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

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

  • Review of Quality Control analysis and results to support product release

  • Release or reject raw materials, intermediates, packaging and labelling materials

  • Conduct Quality on the Floor activities including, but not limited to, quality walk-throughs, change-over and line clearance

  • Provide Quality support to Manufacturing personnel on the floor; provide guidance during GMP events and initiation of deviation investigations

  • Review validation protocols and reports

  • Author, revise and track Standard Operating Procedures

  • Assist on changes that potentially impact intermediate or API, drug substance, and drug product quality

  • Assist on the investigation and resolution of quality related complaints

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


  • Bachelors degree in Biology, Chemistry, Life Science, or Engineering is required. The ideal candidate will have at least +5 years of biopharmaceutical industry experience.

  • Previous experience to GMP manufacturing of cell therapy or biological products is required. Experience working with CMOs is preferred.

  • Experience with cell therapy production processes and viral transduction principles and processes 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 will be highly valued.

  • Willingness to travel up to 10%.

Nkarta offers a creative, team-oriented scientific environment, along with a strong compensation package that includes salary, stock options, and a comprehensive benefits package.



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