Manager/Sr. Manager Quality Control

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 QC Professional to join our team with expertise in QC and cell-based assays, critical reagents, and stability program management. The qualified candidate will coordinate closely with internal and external partners in a cross-disciplinary team of immunologists, engineers, and clinicians to develop and implement best practices in cell therapy manufacturing.

Responsibilities

• Responsible for managing the critical reagents, data review, internal and external stability program for various projects in clinical development.
• Will establish a dedicated QC data review team with the ability to work independently to think through results, resolve data discrepancies, and ensure data integrity. Added ability to review data across multiple documents for consistency.
• Identifies opportunities for continuous improvement and implements/maintains solutions.
• Manage stability study initiation and pulls for starting materials, drug substances, and drug products.
• Leverage statistical software such as JMP to conduct thorough statistical analyses, guaranteeing accurate data interpretation and compliance with regulatory standards.
• This involves tasks such as establishing, executing, and overseeing stability databases; forecasting studies and tests; performing data and control chart trending and statistical analysis; reporting on key metrics.
• Authors, revises, reviews, and approves SOPs, stability protocols and reports, memos, and regulatory documents.
• Participate in cross functional planning to align QC resources and constraints with business objectives.
• Manage and lead a team within prescribed timelines and budgets.
• Own and support stability related deviations, out of specifications, CAPAs, and change controls.
• Support inspection and audit readiness plans.
• Participate in daily and weekly operation meetings and Quality Management Reviews.

Qualifications

• Previous experience in QC is required. Experience with cell therapy is strongly preferred.
• Ability to multi-task, prioritize work assignments, delegate roles and responsibilities appropriately, and provide support where needed.
• Strong team leader with proven ability to identify and support team strengths while acknowledging and strategizing team weaknesses. Proven ability to motivate teams.
• Excellent written and verbal communication skills.
• Demonstrated high degree of organization in terms of goal setting and achieving.
• Independence and creative problem-solving abilities; comfort working in a dynamic and fast-paced environment.
• Demonstrated troubleshooting experience with a focus on accurate data analysis.
• Integrity, confidence, passion and collaborative spirit are highly valued.

Education/Background

• Bachelor's degree in Biology, Chemistry, Life Science, or Engineering is required; advanced degree is preferred.
• 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.

A reasonable estimate of the current salary range for this position is $146,000 - $198,000.  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 https://www.nkartatx.com.