Nkarta Therapeutics is a publicly traded (Nkarta NKTX symbol), 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.

Position Summary

Nkarta is seeking a highly motivated Senior Manager/Associate Director, Manufacturing to join our team. They will lead the Manufacturing team in supporting our efforts in an exciting new area of cancer immunotherapy. This position is based out of South San Francisco, CA.

This person will be responsible for managing a team of cell culture manufacturing specialists in a commercial pharmaceutical environment. In this role you will report to the Executive Director of Manufacturing.

Responsibilities

·       Experience in a regulated biotech or pharmaceutical setting and will have proven competency and expertise in the GMP manufacture of cell-based therapies

·       Lead and manage DS and DP CMOs. Activities include tech transfer, and manufacturing oversight (i.e. execution to release). Lead the internal meetings tied to each CMO for preparedness and readiness of activities. These following activities are oversight and execution with the CMOs:

·       Ensure the production and resource schedule executed against operational plan

·       Ensure performance of all process steps specific to the phase or stage of operation

·       Ensure to have internal process monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements

·       Complete the final review of completed manufacturing documentation per compliance standards and established timelines

·       Investigate and resolve problems, identifying root cause, and proposing process improvements through clear communication to senior management

·       Generate SOPs, batch records, and other quality documents for equipment and procedures used by the CMO

·       Travel would be involved in the role as the Person-in-Plant

·       Lead and manage the start-up of the commercial cell therapy manufacturing facility of activities with the qualification of the equipment. Work the vendor on commissioning of the equipment, work with the internal team on the design space of the area, work with engineers on the built. Candidate needs to be creative and comfortable with building from the start. With the involvement in this work stream, this role will grow into future responsibilities with the commercial facility.

·       Build a team, provide necessary training and ongoing coaching, discipline and recognition of direct staff, including performing annual performance reviews

·       Interact with outside vendors and senior management

·       Participate in multi-functional project teams, as necessary

·       Take corrective action to bring about required changes using change control procedures

 

Requirements

·       Bachelor’s degree in biology or related field (or equivalent experience required), advanced degree preferred with at least 12 years of experience managing a manufacturing team in the biotechnology or biologics industry

·       Previous cell culture experience preferred

·       Travel would be involved in the role as the Person-in-Plant

·       Able to build and manage a team as well as train entry-level personnel

·       Knowledgeable of the current Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's)

·       Understanding of process, systems and equipment to troubleshoot problems

·       Expert knowledge of quality systems

·       Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment

·       High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles

·       Willingness to think outside of the box and adapt best practices to our small, but growing environment

·       Ability to adapt in a constantly evolving environment

·       Self-motivated with a strong sense of ownership in areas of responsibility

 

 

About Nkarta

 

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.

 

Working at Nkarta

 

The 130+ 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