Quality Control, Research Associate (CMC)
South San Francisco /
Graphite Bio is a clinical-stage biotechnology company focused on harnessing the power of targeted DNA integration. Graphite Bio uses next-generation CRISPR based technology platforms for developing curative gene correction-based stem cell therapies for serious and life-threatening genetic diseases with inadequate existing treatment options
In collaboration with the CMC leadership team, this role will be responsible for hand on support of the manufacturing, testing, and release of drug substance and drug product beginning at the pre-clinical stage and continuing through commercial launch. The Research Associate will collaborate on support for all technical operations for programs and processes within the CMC group at Graphite Bio.
What You Will Do:
- Provide operational support for the development and execution of processes for complex cell and gene therapies using gene editing methods like CRISPR/Cas9
- Perform analytical testing using methods like flow cytometry, ddPCR and CFU assays during development, scale up runs, and release of product for human use.
- Perform flow cytometry, ddPCR, CFU and other such assays in collaboration with partner CROs and CDMOs for clinical products according to GMP and GLPs.
- Perform hands on work in the QC testing labs and provide training on GMP cell and gene therapy manufacturing and testing.
- Work cross-functionally with the process development, analytical development, translational development, quality, and clinical development teams to execute on corporate goals
- Write and review technical documents including SOPs, batch records, analytical methods, procedures, method transfer protocols and summary reports.
- Collaborate on tech and method transfer activities amongst Contract Service Providers to confirm that they have the required scientific and technical expertise, equipment and facility capabilities, and quality/compliance standards to conduct CMC related activities
- Review analytical data results generated at Contract labs to ensure the methods are conducted per agreed standards and the results are valid.
- Assist with the integrated process to transfer technology from the research to the development programs to the clinical manufacturing facility. This includes performing the QC activities for the Sickle-cell disease program and maintaining training on site-specific SOPs and procedures.
- As required, design and monitor studies performed by selected Contract Service Providers. Perform data analysis and prepare or review final report(s) for all such studies to ensure scientific integrity and compliance with regulatory requirements
What You Will Bring:
- A minimum of a Bachelor’s Degree in biology, pharmaceutical sciences, biotechnology or related field
- 2+ years’ experience in a related position in a pharmaceutical or Biotech Company
- Experience with multi-color Flow cytometry and PCR is required.
- Experience relevant to cell and gene therapies preferred
- Experience with aseptic technique and cell culture
- Experience with multi-color flow cytometry and PCR methods like ddPCR
- Excellent teamwork and collaboration skills
- Outstanding written and verbal communication skills.
- Understanding of FDA guidelines and GMP regulations.
- Ability to organize and multi-task as needed in a start-up environment.
Fit with Graphite Bio’s culture:
Ability to build strong relationships with co-workers of various backgrounds and expertise
Ability to function at a high level in a team setting whether leading the group or acting as an individual
Values-based leadership consistent with Graphite Bios’ Core Values
Excitement about the vision and mission of Graphite Bio
Competitive salary with equity
Graphite Bio is an equal opportunity employer, and all qualified applicants will receive consideration for
employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national
origin, protected veteran status, or disability status, or any other characteristic protected by law.