Cell Therapy Associate
Founded at the birthplace of biotechnology, Nkarta’s mission is to discover, develop and deliver novel off-the-shelf (e.g. allogeneic) natural killer (NK) cell therapies that profoundly impact patients’ outcomes and survival. The company is based on the proprietary, robust and well-characterized NK cell expansion technology pioneered by Dr. Dario Campana. Nkarta is focused on leveraging the inherent power of NK cells to identify and kill abnormal cells and recruit adaptive immune effectors to generate responses that are deep and durable.
Nkarta combines its NK cell expansion and cryopreservation platform with proprietary cell engineering technologies to generate an abundant supply of NK cells, engineer enhanced NK cell recognition of tumor targets, and improve persistence for sustained activity in the body for the treatment of cancer.
Founded in 2015, Nkarta became a public company (Nasdaq symbol NKTX) in 2020. Our development pipeline of engineered NK cell therapy candidates consists of two co-lead programs, NKX101 and NKX019. The IND for NKX101 for the treatment of relapsed or refractory AML and higher-risk MDS was accepted by the FDA in July 2020. We expect to begin dosing patients in this study by the end of 2020. As we broaden the development of NKX101, we also plan to initiate studies in solid tumors. Our second co-lead program, NKX019, is designed to target B cell lymphomas. We plan to file our IND for NKX019 with the FDA in early 2021. In addition, we recently completed the construction of a GMP compliant clinical manufacturing facility in our South San Francisco location designed to produce viral vector and supply our initial clinical trials.
Position Title Cell Therapy Associate
Location South San Francisco, CA
Reports to Associate Director, Manufacturing
Working with other members of the manufacturing team, this role supports the successful tech transfer and operational readiness processes including the GMP manufacture and release of cell therapy products. ,
· Supports the successful tech transfer and operational readiness processes using knowledge of cGMP regulations to ensure manufacturing readiness.
· Supports the GMP manufacture and release of cell therapy products; follows all processes and procedures related to operations in full compliance with cGMP, CFRs, site quality systems and company policies; and promotes a culture of quality and compliance.
· Performs process unit and support operations described in standard operating procedures (SOPs) and batch records including: media and solution preparation, cell drug substance preparation; and drug product fill operations.
· Performs all tasks associated with the manufacture of commercial product following batch records and SOPs.
· Works as part of a small team to execute GMP runs in close collaboration with process development and quality.
· Assists in the development of standard operating procedures, batch records, deviations and change controls.
· Successfully troubleshoots processing and equipment issues.
· Works with documentation required by protocols, SOPs, and batch records.
· Maintains aseptic technique during processing of products to ensure the integrity, viability and sterility of cell therapy products from thaw to final formulated drug product cryopreservation.
· Performs tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.
· Completes on a timely basis training assignments to ensure the necessary technical skills and knowledge are applied compliantly during GMP operations.
· Assists in setting up manufacturing areas and equipment, including complex automated cell processing, cell expansion and filling equipment.
· Updates and revises manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
· Routinely monitors, cleans, prepares and operates processing and analytical equipment in Grade B/C areas.
· Follows all cleaning and gowning procedures for the facility.
· Maintains and applies knowledge regarding donor information, screening and testing, labeling and product acceptability and release criteria.
· Is flexible and adaptable to schedule and procedural changes to ensure timely preparation of products with the highest quality.
· Maintains current inventory of supplies kept in specified kitting and staging areas and CAR-T suites.
· Embodies the company culture of empowerment, diversity, and inclusion.
· Knowledgeable and able to operate successfully in an aseptic processing environment with Grade A biosafety cabinets and Grade B clean rooms.
· Able to work with standard universal precautions for handling human derived materials in BSL-2 containment areas.
· Knowledgeable of cGMP regulations and FDA guidance applicable to biologics and/or cell therapy.
· Excellent interpersonal, oral and written communication skills.
· Willing and able to work off-shift and long hours as needed.
· Able to perform frequent periods of sitting, walking, and standing.
· Willing and able to frequently use personal protective equipment.
· Able and willing to perform occasional climbing of stairs or ladders, bending or stooping, crouching or squatting.
· Able to perform occasional fine finger dexterity/ including grasping or pinching.
· Willing and able to occasionally use hazardous materials and chemicals.
· Able and willing to work in cold rooms and freezers occasionally.
· Works well in a team-based environment.
· Experience in cell culture processing including the handling and propagation of human primary cells.
· Strong technical writing ability highly desirable.
Education / Background
· Bachelors or Associates in relevant science or engineering discipline with 1-3 years of experience in cGMP biologics or cell therapy manufacturing; or
· 3+ years in cGMP manufacturing biologics or cell therapy manufacturing
This position requires the ability to frequently lift and/or move up to 30 pounds. Specific vision abilities for this job include close vision, depth perception, and ability to adjust focus. GMP compliant gowning in aseptic work areas is common and is required. Color, vision, and depth perception required for inspection or test related jobs. The common requirements of an office environment (computers, computer screens, workstations, etc.) apply when not working in or around the laboratory environment.
The 70+ team members at our South San Francisco, California headquartered location describe working at Nkarta, along with opportunities for improvement, in some of the following ways:
“Work is interesting – lots of projects in the pipeline (so I don’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 are enjoyable.”
“I like that the company is open minded with a (people) –(looking for) a set of skills that can grow (as opposed to thinking you have to have exactly what’s in a job spec now) Things that broaden their (employees) skills and growth.”
“Like any startup there are fires to put out; feel confident we have the people to control those fires.”
“Diverse people from different backgrounds.”
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