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Associate Process Engineer/Process Engineer I

Employer
Graphite Bio
Location
South San Francisco, CA
Start date
Sep 15, 2022

View more

Discipline
Engineering, Manufacturing & Production, Process
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Biotech Bay, NextGen Bio
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Job Details

Graphite Bio is a clinical-stage, next-generation gene editing company harnessing high efficiency targeted gene integration to develop a new class of therapies to potentially cure a wide range of serious and life-threatening diseases. Graphite Bio is pioneering a precision gene editing approach that could enable a variety of applications to transform human health through its potential to achieve one of medicine’s most elusive goals: to precisely “find & replace” any gene in the genome. Graphite Bio’s platform allows it to precisely correct mutations, replace entire disease-causing genes with normal genes or insert new genes into predetermined, safe locations. The company was co-founded by academic pioneers in the fields of gene editing and gene therapy, including Maria Grazia Roncarolo, M.D., and Matthew Porteus, M.D., Ph.D.

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The Role:

We are seeking a talented Process Development Associate/Process Engineer I to contribute to our process development and optimization efforts for our ex-vivo cell and gene therapy programs. You will be a critical team member for supporting the early and late stage scale up and engineering activities of Graphite Bio’s manufacturing process. In addition, you will collaborate on relevant major investigations, perform data analysis and visualization, and advance process improvement and process characterization development work.

What You Will Do:

  • Execute development studies and process optimization studies for Graphite Bio’s manufacturing platform for ex-vivo gene-corrected hematopoietic stem cells
  • Contribute towards building a science-based understanding of the process to establish process operating ranges and define critical process parameters (CPPs) and proven acceptable ranges (PARs) to enable robust cell manufacturing processes
  • Perform hands on work in the cell culture labs for development and clinical scale processing
  • Support the execution of analytical assays
  • Perform CD34+ cell selections from mobilized apheresis using the CliniMACS platform and perform optimization experiments to ensure a high quality, consistent inventory of human cells and tissues (HCT) for use as starting material in PD labs
  • Participate in risk assessment studies to evaluate process change impact
  • Analyze data and perform statistical analysis of large datasets
  • Assist with the integrated process to transfer technology from the development phase to the clinical manufacturing facility
  • Support technical investigations in the event of deviations and provide oversight of the end-to-end process deviations in close coordination with all relevant functions
  • Write and review technical documents including SOPs, batch records, test procedures, work instructions and summary reports
  • Participate in tech transfer activities with CMOs and deliver onsite manufacturing support as needed

What You Will Bring:

  • 2+ years of hands-on experience with bioprocessing for cell and gene therapies in an industrial setting (manufacturing, process development, analytical development, research). Experience with performing cell selections, electroporation, viral transduction, and cell culture highly preferred
  • Self-motivated and comfortable working in a fast-paced laboratory environment
  • A willingness and interest in contributing towards projects outside of one’s routine assigned work
  • Highly driven and organized with a strong attention to detail. Prioritizes excellence in operations
  • Experience in data management and analysis using excel. Experience with data analysis and visualization using GraphPad Prism and JMP preferred
  • Experience in experimental design, summarizing and presenting data, and authoring technical reports
  • GxP experience, especially with respect to GDP and maintaining accurate electronic laboratory notebooks
  • Up to 20% travel within North America

What Graphite Will Bring:

At Graphite Bio, we are intentionally building a community that is inspired, diverse, and curious. For this role, and all roles, we seek someone who is:

  • Determined. You share our mission to bring curative gene editing to patients. And you know the need is urgent.
  • People-focused. You prioritize relationships. You value differences and are an excellent listener.
  • Adaptable. You seek solutions, even when things change. You prefer to find your way to “yes!”

EEO Statement

Graphite Bio is an equal opportunity employer. We believe that our strength is in our differences. Our goal to build a diverse and inclusive team began on day one, and it will never end. 

COVID-19 Policy

All company employees, regardless of work location, must be fully vaccinated for COVID-19. Fully vaccinated means a person has received all recommended doses in their primary series COVID-19 vaccine. Requests for an accommodation/exemption for medical or religious reasons, as well as under applicable state law, will be considered on a case-by-case basis consistent with applicable law.

  To all recruitment agencies: Graphite Bio does not accept agency resumes or applications. Please do not forward resumes to our jobs alias, or Graphite Bio employees. Graphite Bio is not responsible for any fees related to unsolicited resumes or applications.

Company

Graphite Bio is driven to apply its breakthrough technology with urgency to advance therapies and cures for people living with serious diseases. 
 
Graphite Bio is a next-generation gene editing company focused on the development of potentially curative therapies for patients suffering from serious diseases. The company's targeted gene integration platform harnesses the natural cellular process of homology directed repair (HDR) to efficiently repair genetic defects at their source, deliver genetic cargo with precision and engineer new cellular effector functions. Graphite Bio is leveraging its differentiated platform, initially focused on ex vivo engineering of hematopoietic stem cells, to advance a portfolio of transformative treatments with potential for saving and dramatically improving patients' lives. The company was co-founded by academic pioneers in the fields of gene editing and gene therapy, including Maria Grazia Roncarolo, MD, and Matthew Porteus, MD, PhD, and is backed by Versant Ventures and Samsara BioCapital. 
 
More information is available at www.GraphiteBio.com. 

Find Us
Website
Location
279 E Grand Ave, Suite 430
South San Francisco
CA
94063
United States
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