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 Scientist to join a growing team in Analytical Development to drive analytical method development and tech transfer to support clinical stage manufacturing of our gene editing and cell therapy pipeline. This person will be responsible for planning and design, execution, and analysis of experiments for the development assays in support of process development, drug product release/characterization, process characterization and product/process comparability studies. The Scientist should be curious with an ability to communicate complex scientific concepts and vision to an audience of other scientists, associates, and management to gain broad understanding. The ideal candidate is flexible and able to adapt to a dynamic team environment by maintaining a constant stream of communication with leadership, peers, and associates. The products we are developing are cutting edge technology and the Scientist will be asked to develop cutting edge technologies to interrogate these new medicines.
What You Will Do:
- Plan assay development activities, design and execute experiments to drive plan to completion
- Author and review technical reports to support assay development and tech transfer activities
- Author and review test methods based on assay development
- Author and review test method qualification and validation protocols and reports
- Optimize test methods and perform assessment of method performance
- Lead method tech transfers by providing subject matter expertise in several methods
- Assist in the planning and development of robust control systems for drug product release
- Assist in the development of drug substance intermediate and drug product characterization plan
- Help in the design and planning of drug product comparability studies
- Compile drug product and drug substance release, characterization, and in process data to support assay and process development as well as regulatory filings
- Work with Analytical and process development leadership as well as quality colleagues to develop data handling and tracking programs and standard operating procedures
What You Will Bring:
- MS with 7+; PhD with 2+; years of industry experience
- Demonstrated subject matter expertise in multiple methods used routinely in cell and gene therapy (ELISA, flow cytometry, PCR, cell-based methods, etc.)
- Analytical and process tech transfer experience is a must
- Demonstrated analytical method development expertise from planning/design through method qualification/validation
- Ability to prioritize tasks in a fast-paced complex environment to achieve department and company goals
- Expertise in hematopoietic stem cell derived drug products is highly desired
- Expertise in ex-vivo gene therapies is highly desired
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.