Position Title: Senior Process Development Engineer/Process Development Engineer - Late-Stage Cell Therapy
Location: South San Francisco, CA
Reports to: Director of Cell Therapy Process Engineering and Scale-up
Nkarta is a publicly traded (Nasdaq symbol NKTX), South San Francisco headquartered, early-stage biopharmaceutical company focused on the discovery, development and commercialization of allogeneic, off-the-shelf engineered natural killer, or NK, cell therapies to treat cancer.
The role is responsible for supporting the planning, execution, and technical support of manufacturing process scale-up and technology transfer project tasks/activities, in which drug substance and drug product operations are transferred from Process Development to Manufacturing in order to produce quality product at cGMP manufacturing scale in support of both clinical and future commercial programs
· Collaborates with key departments and personnel in technology transfer projects
· Supports implementation of new processes in manufacturing operations.
· Assists or leads implementation of new manufacturing equipment or raw materials to enable transition from early clinical trials to late stage and commercial GMP processes
· Helps in or manages manufacturing process improvements/changes requiring cross-functional oversight
· Supports evaluation of process scale and manufacturability with early phase development, evaluating facility fit and equipment capability, and determining manufacturing process control strategy
· Optimizes processes and procedures to collaboratively create manufacturing efficiency, process robustness and reduced costs including experiments conducted both at lab and pilot scale.
· Demonstrates a high level of initiative in troubleshooting experiments and accurate data analysis.
· Participates in cross-functional collaborations to meet project timelines and material supply requirements.
· Preferred experience with bioprocess scale-up and technology transfer, extensive technical knowledge and expertise in the manufacturing production of cellular therapeutics and/or protein therapeutics products also applicable.
· Preferred experience in:
· Suspension based-bioreactor for the culture of mammalian-cell lines
· Flow cytometry
· GMP manufacturing of cell therapy or biological products
· Ideal to possess experience in:
· Development or production of cell therapies
· Genetic editing and viral transduction principles and processes
· Thorough understanding of Design of Experiments (DOE) and Quality by Design (QBD).
· Highly organized, detail-oriented individual with strong problem-solving skills.
· Excellent verbal and writing skills for documentation of data, drafting of technical reports, and communication of progress to supervisor and project teams.
· Must be able to communicate and multi-task within a fast-paced, highly collaborative team environment with a high degree of self-motivation and organization.
· Embodies the company culture of empowerment, diversity, and inclusion.
Education / Background
· Bachelors or Master’s in biology, engineering or related discipline with 2 or more years of related process development or laboratory experience within the biologics industry, with preferably within cell therapy.
This position requires the ability to occasionally lift and/or move up to 30 pounds and stand for multiple hours at one time. Specific vision abilities for this job include close vision, depth perception, and ability to adjust focus. Able and willing to gown in an aseptic environment on a regular basis. The common requirements of an office environment (computers, computer screens, workstations, etc.) apply when not working in or around the laboratory environment.
Founded in 2015 at the birthplace of biotechnology, our development pipeline of engineered NK cell therapy candidates includes two co-lead clinical programs, NKX101 and NKX019. Clinical trials for 101 are in process; 019 will begin in H2 2021. Nkarta recently announced a collaboration with CRISPR Therapeutics, a world leader in gene-based medicines, for the development and commercialization of up to three new cell therapy candidates and access to clinically validated CRISPR/Cas9 genome engineering.
Complementing our broad research and development capabilities, Nkarta has also built an extensive cell therapy manufacturing operation. We have a 2,700-square foot clinical good manufacturing practice, or cGMP, facility on-site at our primary corporate location in South San Francisco, California. We plan to start in-house manufacturing of NKX019 in 2021 and NKX101 in 2022. We are also currently designing a separate, larger cGMP facility, to supply our anticipated pivotal clinical trial and commercial needs.
The 100+ 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 in which we’re working, here are real anonymous comments of 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