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 manufacturing sciences and technologies engineer to contribute to our pipeline scalability and manufacturability efforts in conjunction with our internal development teams, and our external manufacturing and release partners. You are a critical team member for the process and analytics during campaign preparation as well as production; in addition, you will collaborate on relevant major investigations, process adaptations and continuous improvements, for the Graphite hematopoietic stem cell products.
What You Will Do:
- The MSAT Engineer will be responsible for on-going development and transfer (both analytical and process) of cell therapy and viral vector programs into late phase GMP production. You will:
- collaborate with cross-function internal and external teams, including process development, quality, external manufacturing, and program management
- represent Graphite at external facing meetings and provide technical guidance to collaborators
- provide guidance and support to members of the organization on technology transfer related activities
- The MSAT Engineer will also have Subject Matter Expert (SME) accountabilities including:
- Facility fit, gap evaluation, and other process assessments for Graphite outsourced operations
- Oversee failure modes and effects analysis (FMEA) guidance with external collaborators with guidance from senior members of the organization
- Drafting equipment characterization and scale out plans
- Authoring of process flow diagrams and technology transfer process descriptions, reviewing of bills of materials, external collaborator documentation, and production batch records
- Providing support to enable GMP execution during new process introductions, support discrepancies and investigations, corrective actions and preventative actions (CAPAs), and change controls
- Phase appropriate process characterization and analytical development/qualification in support of phase appropriate activities across cell therapy and viral vector processes; additional characterization, qualification, and validation activities for other intermediate drug substances may be required
- Learn, do, teach – you will gain hands on experience with the Graphite pipeline processes and analytics, develop/implement techniques in an internal Graphite setting, then teach our external partners how to best work with our autologous process
- Communicate technical data and make appropriate conclusions effectively internally and externally
- Establish and contribute positivity to the broader vision of company culture
What You Will Bring:
- 5+ years of hands-on experiences various immune cell types (red blood cells, macrophages, monocytes, T and B cells) in an industrial setting (manufacturing, process development, analytical development, and/or quality control), with preference for individuals with hands on gene editing experience
- Experience with current Good Manufacturing Practices (cGMP) and manufacturing support (cell and gene therapy preferred)
- Knowledge of both US and EU regulations; ability to learn relevant modeling techniques useful for continuous process monitoring a plus
- Able to effectively present information and ideas, both formally and informally, in writing or verbally, to various stakeholder groups
- Embraces a culture of safety at all times and prioritizes excellence in operations
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.