Careers

quality control head

Department: Quality
Location: South San Francisco
 

COMPANY INTRODUCTION:

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.

KEY RESPONSIBILITIES:

  • Hire QC personnel to enable performance of all QC functions

  • Lead the QC team

  • Implement QC procedures and practices

  • Develop plan for the qualification of the new QC laboratory as well as organization of the QC laboratory equipment

  • Perform instrument and method qualification (method qualification will be phase appropriate)

  • Ensure product testing is appropriately completed (most assays are cell-based (e.g., flow cytometry, PCR, cellular imaging, etc.)

  • Ensure that out of specifications and deviations are appropriately investigated and resolved

  • Initiate change controls

  • Write, review, and approve validation protocols and reports

  • Participate in product quality reviews

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

  • Support investigational new drug (IND) chemistry-manufacturing-control (CMC) section writing

  • Participation in risk assessments

  • Ensure that adequate personnel are available to perform the QC functions

PROFESSIONAL EXPERIENCE/QUALIFICATIONS:

  • Bachelors degree in Biology, Chemistry, Life Science, or Engineering is required; advanced degree is preferred. The ideal candidate will have at least 10-15 years of biopharmaceutical industry experience.

  • Previous experience in QC experience is required.  Experience with cell therapy is preferred.

  • Experience with setting up and developing an entire QC lab is a plus.

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

  • Experience in managing and leading small teams within proscribed timelines and budgets.

  • 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.

 

 

To apply Attach your CV Here