30+ days ago
South San Francisco, CA
Quality Assurance Specialist
Nkarta is a clinical-stage biotechnology company advancing thedevelopment of allogeneic, off the shelf natural killer (NK) cell therapies forcancer. By combining its cell expansion and cryopreservation platform with proprietarycell engineering technologies, Nkarta is building a pipeline of cell therapycandidates generated by efficient manufacturing processes, which are engineeredto enhance tumor targeting and improve persistence for sustained activity inthe body.
Founded in 2015 at the birthplace ofbiotechnology in South San Francisco, CA, Nkarta became a public company (Nasdaq symbol NKTX)in 2020. Our development pipeline of engineered NK cell therapy candidatesconsists of co-lead programs, NKX101 and NKX019. The IND for NKX101 for the treatmentof relapsed or refractory AML and higher-risk MDS was accepted by the FDA inJuly 2020. Patient dosing began in Q4 2020. As we broaden the development ofNKX101, we also plan to initiate studies in solid tumors. Our second co-leadprogram, NKX019, is designed to target B cell lymphomas. We plan to file ourIND for NKX019 with the FDA in early 2021.
Position Title QA Specialist
Location SouthSan Francisco, CA
Reports to Sr. Manager, Quality Assurance
Nkarta offersa unique opportunity for a highly-motivated QA Specialist to join our growing QualityAssurance team. This role supports thequalification of our new manufacturing site and technical transfer of advancedNK cell therapies. It’s also a keyposition to closely coordinate with internal and external partners in across-disciplinary team of immunologists, engineers, and clinicians to developand implement best practices in cell therapy manufacturing.
· Supports activities forreleasing or rejecting intermediates, API, drug substance, and drug products.
· Reviews completed batchproduction and laboratory control records of critical process steps beforerelease of the product for distribution.
· Reviews of QualityControl analysis and results to support product release.
· Releases or rejects rawmaterials, intermediates, packaging and labelling materials.
· Conducts Quality on theFloor activities including, but not limited to, quality walk-throughs,change-over and line clearance. Assists on changes that potentially impactintermediate or API, drug substance, and drug product quality.
· Assists in theinvestigation and resolution of quality related complaints
· Participates incross-functional collaborations to meet project timelines and material supplyrequirements
· Previous experience with GMP manufacturing of cell therapy or biologicalproducts is a plus.
· Excellent communication skills, bothwritten and oral, and high degree of organization in terms of goal setting andachieving.
· Independence and creativeproblem-solving abilities; comfort working in the fluid structure of start-upbiotech.
· Integrity, confidence, passion andcollaborative spirit are highly valued.
· Willingness and ability to travel upto 10%.
· Embodies the Nkarta culture ofempowerment, diversity, and inclusion.
· Experience working with CMOs.
· Experience with cell therapyproduction processes and viral transduction principles and processes.
Education / Background
· Bachelors degree inBiology, Chemistry, Life Science.
· 5+ years of biopharmaceutical industry experience.
WorkEnvironment / Physical Demands
Thisposition 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 oraround the laboratory environment. Car and airplane travel might be requirementof this role.
Working at Nkarta
The 90+ team members at our South SanFrancisco, California primary location describe working at Nkarta, along withopportunities for improvement, in some of the following ways:
“Work is interesting – lots of projects in the pipeline (so Idon’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 areenjoyable.”
“I like that the company is open minded with a (people) –(lookingfor) a set of skills that can grow (as opposed to thinking you have to haveexactly what’s in a job spec now) Things that broaden their (employees) skillsand growth.”
“Like any startup there are fires to put out; feel confident wehave the people to control those fires.”
“Diverse people from different backgrounds.”
To learn more about our work at Nkarta and the careeropportunities that will drive us forward to serve patients, please visit thecompany’s website at https://www.nkartatx.com