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.
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!”
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.
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.