Director, Sr Director Quality Control

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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.

This position oversees the Quality Control (QC) Department, including analytical, microbiological, raw material, and analytical method qualification groups. The candidate is responsible for internal and external QC in-process, drug substance, drug product, and stability testing. The Director/Senior Director of QC will be responsible for tech transferring methods and starting up the new QC lab.

Responsibilities

• Hire and lead the QC personnel to enable performance of all QC functions
• Implement and improve QC procedures and practices
• Develop and oversee qualification plan for the new QC laboratory as well as organization of the QC laboratory equipment
• Oversee instrument and method qualification (method qualification will be phase appropriate)
• Ensure product testing is appropriately completed (most assays are cell-based (e.g., flow cytometry, PCR, cellular imaging, etc.)
• Ensure that out of specifications and deviations are appropriately investigated and resolved
• Initiate change controls
• Write, review, and approve validation protocols and reports
• Participate in product quality reviews
• Participate in cross-functional collaborations to meet project timelines and material supply requirements
• Support investigational new drug (IND) chemistry-manufacturing-control (CMC) section writing
• Participation in risk assessments
• Ensure that adequate personnel are available to perform the QC functions
• Ensure that QC is in compliance with appropriate regulations (e.g., FDA, ICH, etc.)

Qualifications

• Previous QC experience is required. Experience with cell therapy is preferred.
• Experience with setting up and developing an entire QC lab is a plus.
• Excellent communication skills, both written and oral, and high degree of organization in terms of goal setting and achieving.
• Experience in managing and leading small teams within proscribed timelines and budgets.
• Independence and creative problem-solving abilities; comfort working in the fluid structure of start-up biotech. Integrity, confidence, passion and collaborative spirit will be highly valued.
• Willingness to travel up to 10%.

Education/Background

• Bachelors degree in Biology, Chemistry, Life Science, or Engineering is required; advanced degree is preferred. The ideal candidate will have at least 10-15 years of biopharmaceutical industry experience.

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; however, the work hours are flexible as agreed upon.

A reasonable estimate of the current salary range for this position is $225,000 - $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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