Sr. Manufacturing Associate

Nkarta, Inc. South San Francisco , CA 94080

Posted 3 days ago

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.

Overview

Support the daily GMP manufacturing operations of allogeneic NK cell therapies while driving facility and equipment qualifications, initiating and assessing deviations, reviewing batch records, and authoring SOPs.

Responsibilities

  • Supports technical transfer of new products/processes by collaborating with other members of the CMC team (PD, MSAT, Quality, Supply Chain, etc.).

  • Supports in setting up manufacturing areas and equipment/fixtures. Performs facility and equipment/environmental monitoring activities.

  • Performs manufacturing processes on the floor, following batch records and standard operating procedures (SOPs) to ensure safe and compliant operations.

  • Ensures right-the-first-time performance of all process steps specific to the phase or stage of operation.

  • Completes training assignments to ensure the necessary technical skills and knowledge.

  • Works as part of a team to execute GMP runs in close collaboration with other areas of CMC.

  • Performs Aseptic Filling unit operations for the manufacture of products in a cGMP environment using proper aseptic technique, good documentation practices, and sound scientific methods.

  • Operates automated filling equipment and the execution of the manufacturing processes from filling to cryopreservation of product using batch records.

  • Rigorously adheres to SOPs and cGMP regulations and accurately completes documentation associated with clinical manufacturing.

  • Supports development of SOPs, MBRs, and other process documents, as well as deviations and change controls.

  • Escalates processing and equipment issues as needed.

  • Reviews daily in-process cGMP documentation for completeness and accuracy

  • Participates in any operational excellence initiatives such as 5S, Kaizen, lean manufacturing and continuous improvement

  • Embodies the company culture of empowerment, diversity, and inclusion.

Qualifications

  • Knowledge of the current Good Manufacturing Practices (cGMP's).

  • Knowledgeable in Microsoft Word, Excel and data analysis.

  • Self-motivated and willing to accept temporary responsibilities outside of initial job description.

  • Excellent interpersonal, verbal and written communication skills.

  • Willingness to think outside of the box as well as comfortable in a fast-paced and constantly evolving environment.

  • Able to work off shift hours and weekends.

  • Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.

Preferred

  • Excellent aseptic/sterile techniques and prior experience with biopharmaceutical manufacturing; previous experience with cell or gene therapy manufacturing.

Education / Background

  • Accepting all experience levels. Position level will be adjusted to match. 2 years or more years of experience in cGMP biologics cell culture manufacturing, experience in biotech or cell therapy manufacturing with a bachelor's degree in biology or related scientific discipline, or equivalent combination of experience and education preferred

Working at Nkarta Inc.

This position requires the ability to occasionally lift and/or move up to 30 pounds and stand for multiple hours at one time. Specific vision abilities for this job include close vision, depth perception, and ability to adjust focus. Able and willing to gown in an aseptic environment on a regular basis.

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 $113,568 - $130,000. 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.


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