Senior Manufacturing Associate/Manufacturing Associate

Job Locations US-CA-South San Francisco
ID
2022-1074
Category
Manufacturing
Position Type
Regular Full-Time

About Us

Nkarta is a publicly traded (Nasdaq symbol NKTX), 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.

 

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.

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

  • Assists with technical transfer for new products by collaborating with other members of the CMC team (PD, Quality, etc.).
  • Assists in setting up manufacturing areas and equipment/fixtures. Performs facility and equipment 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.
  • Assists with 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 Environment

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.

Working at Nkarta Inc.

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

 

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed