Cell Therapy Drug Product Engineer 2 – PD/MSAT

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.  

We are seeking a highly motivated and collaborative Engineer to join the Process Development/Manufacturing Science and Technology (PD-MSAT) team in developing and supporting Nkarta’s pipeline of cellular immunotherapy platform and products.  This role will primarily represent CMC in our ongoing clinical operations and drug product development. Priorities will include investigations in support of drug product formulation/filling as well as drug processing characterization activities including technology transfer of drug product processing for clinical and future commercial programs.

• Represent Nkarta cross-functional CMC interests as part of internal and external clinical operational activities.
• Represent Nkarta externally in support of clinical site training for Nkarta’s pipeline products
• Support the optimization of handling logistics and processing for formulation, fill and finish operations of cell therapy product
• Train and support cell therapy technicians and specialists in the dose preparation procedure at clinical sites
• Perform in-house experiments to test new materials and methodology to optimize drug product handling and preparation processes.
• Perform statistical analysis on clinical data regarding the preparation for the drug product processing in internal investigations as well as any relevant data collected externally
• Solve technical issues as well as evaluate and implement new technology/instrumentation based on scientific literature and industry trends as well as requirements for GMP production.
• Maintains cell cultures of critical cell lines and generates/characterizes new cell banks.
• Performs routine maintenance of lab equipment.

• Supports process development and engineering studies, evaluation of manufacturability, and implementation of new processes in manufacturing operations.
• Supports process readiness for GMP manufacturing, risk assessments, root cause investigations, and process changes/improvements.
• Participates in cross-functional collaborations to meet project timelines, materials and process readiness requirements.

Required

• Strong general laboratory skills (e.g., excellent aseptic technique, excellent organization of shared lab space)
• Exceptional interpersonal skills and ability to communicate professionally with all levels within the organization
• Ability to travel with a high degree of flexibility
• Has excellent verbal and written communication skills.
• Ability to work independently, multitask, and meet deadlines in a fast-paced environment.
• Experience in cell culture, both primary and cell line, is required.
• Highly motivated, disciplined record keeping, strong attention to detail.

• Highly organized, detail-oriented individual with strong problem-solving skills.

• Embodies the Nkarta culture of empowerment, diversity, and inclusion.

Preferred

• Experience working in or with GMP manufacturing, quality control, or regulated environments is preferred.
• Experience in gene/cell therapy, cell-based assays, process development, process scale up, technology transfer, GMP manufacturing is a plus.
• NK cell, T cell, or stem cell expertise preferred.

Education/Background

• Bachelor’s degree in chemical or biochemical engineering or related field is required.
• At least two years relevant experience in academia, biopharmaceutical or biotechnology industry is a plus.
• 1+ years industry GMP Manufacturing or Process Development experience is preferred.

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; however, the team works a hybrid schedule with work from home days.

A reasonable estimate of the current salary range for this position is $100,000 - $115,000.  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.