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.

   

Location:                    South San Francisco, CA

Reports to                Vice President, Regulatory Affairs

 


Position Summary:

Nkarta is hiring a Director, CMC Regulatory Affairs who will be responsible for leading the regulatory strategy and preparing CMC related regulatory submissions in accordance with applicable regulatory requirements to advance Nkarta’s portfolio of allogenic CAR NK products.

The successful candidate will work closely with the rest of the regulatory affairs group, the technical operations, product and analytical development groups and other key cross functional stake holders including the core project teams to ensure that CMC regulatory requirements are maintained in step with continued clinical development of products in a phase appropriate manner.

In this role you will leverage broad knowledge and expertise to work collaboratively with colleagues in ensuring rapid advancement of Nkarta’s novel products. Nkarta fosters a diverse, supportive and collaborative culture with a can-do attitude and the successful candidate will thrive in an open working environment. The successful candidate will take a creative and company-wide approach to problem solving.

Responsibilities:

·       Working with cross functional teams to effectively implement and execute CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks

·       Provide leadership and guidance for regulatory CMC aspects of product development projects including advising on phase appropriate process improvements

·       Contribute to and review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines

·       Support Regulatory team with discussions and interactions with health authorities to facilitate review and approval of submissions

·       Develop regulatory processes and procedures to support CMC components of regulatory submissions

·       Support the creation and maintenance of CMC submission templates

·       Provides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls

·       Provides interpretation of regulatory guidance documents, regulations and directives – advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs

·       Other duties as assigned

 

Competencies:

·       Knowledge of drug development regulations and guidelines (i.e. FDA, EU and ROW regulations and ICH guidelines) as well as an understanding of CGMPs (Current Good Manufacturing Practices).

·       Strong skills in planning, critical thinking and problem-solving.

·       Ability to work independently, prioritize, coordinate and complete multiple projects within deadline while maintaining a level of attention to detail.

·       Strong experience with CTD format and content regulatory filings

·       Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.

·       Ability to work independently and as part of a team.

·       Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.

Experience/Education:

·       MS/PhD or advanced degree in a scientific/engineering discipline is preferred.

Minimum 5-10 years in pharmaceutical / biopharmaceutical industry (ideally both small and large companies).

·       Prior leadership experience leading teams highly desired

·       Experience in cellular therapy highly desired

·       Experience in immunology, immunotherapy or biological therapy development

 

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