Director, Viral Vector Analytical Development

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Job description

About Us

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 Director of Viral Vector to join the Analytical Development (AD) team in the Technical Operations Department and lead viral vector analytical development and strategy.

Responsibilities

• Oversees viral vector analytical development and testing support with a hands-on presence in the laboratory.
• Manages team of scientists and analysts
• Partners with the Viral PD group to understand and support their analytical needs
• Leads refinement of critical quality attributes (CQA) for which controlled assays must be available for viral lot release and stability, and other attributes which require characterization assays
• Responsible for the selection, design and implementation of viral- and cell-based analytical methods to support virus release and characterization
• Responsible for tech transfer of assays to in-house and CMO QC teams
• Creates, compiles, and reviews databases containing data from various viral assays.
• Strong contributor to viral vector analytical strategy, including development of criteria, with an eye towards late phase pivotal studies.
• Responsible for documentation related to assays supported by the team including procedures, methods, protocols, forms, etc.
• Present scientific results in team and company meetings
• Participate in cross-functional collaborations to meet project timelines

Qualifications

Required

• Retroviral and retroviral-transduced cell-based assay development experience, particularly viral titer, RCR, viral particle measurement, detection of process-related impurities, measures of empty vs full viral particles
• Proven track record developing methods on multiple platforms (e.g. ELISA, molecular, cell-based methods) to characterize retroviruses
• Experience with regulatory filings and guidance supporting the use of viral vectors as drug substances.
• Highly organized, detail-oriented individual with strong problem-solving skills.
• Strong team leader with proven ability to identify and support team strengths while acknowledging and strategizing team weaknesses. Proven ability to motivate teams.
• Ability to apply learnings across areas - understands how data from one area can impact others
• Excellent verbal and written communication skills with demonstrated ability to communicate complex ideas and strategies clearly
• Team player, with ability to work independently, multitask, and meet deadlines in a fast-paced environment.
• Demonstrated troubleshooting experience with a focus on accurate data analysis
• Embodies the Nkarta culture of empowerment, diversity, and inclusion.
• Possesses extensive experience in implementing FDA, ICH, and GMP guidelines, with a particular focus on gene therapy regulations and related guidance, ensuring compliance and quality control in regulated environments.

Preferred

• Experience with viral comparability and late-stage analytical strategies
• Experience with cell-based assays including flow cytometry, cytotoxicity, and sequencing applications such as NGS
• Viral transduction principles and virus manufacturing process experience
• Experience in gene/cell therapy, cell-based assays, immunoassays, ELISAs, droplet digital PCR (ddPCR) and/or qPCR assays in regulated environments is a plus.
• NK cell, T cell, or stem cell expertise

Education/Background

• PhD or equivalent in Virology, Immunology, Cell Biology, or related field; equivalent experience in lieu of advanced degrees is welcomed.
• Eight+ years assay development experience in Cell and Gene Therapy with emphasis on development of methods to characterize viruses.

Working at Nkarta Inc.

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.

A reasonable estimate of the current salary range for this position is $223,000 - $290,000. 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 .

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