Process Development Scientist
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 Associate Director for Process Development, this role will be responsible for all aspects of the development, manufacturing, testing, and release of drug substance and drug product beginning at the pre-clinical stage and continuing through commercial launch. The Process Development Scientist I/II (PD Scientist) will collaborate on the process design, development of strategic direction and support for all technical operations programs and processes.
What You Will Do:
- Lead the process development efforts including the design and development of manufacturing processes for Phase I/II programs
- Strategize on the Design of Experiments and other such product characterization activities for early and/or late stage programs
- Provide operational support for the development of processes for complex cell and gene therapies using gene editing methods like CRISPR/Cas9
- Identify and evaluate outsourced CMOs/CROs and vendors to determine that they have the required scientific and technical expertise, equipment and facility capabilities, and quality/compliance standards to conduct CMC related activities
- Manufacture clinical products at contracted CDMOs or in-house
- Support the continued development of robust, cost-effective, scalable cell manufacturing processes for Graphite Bio’s severe rare genetic disease and oncology pipeline
- Perform hands on work in the cell culture lab and provide training on GMP cell and gene therapy manufacturing
- Work cross-functionally with the process development, analytical development, translational development and clinical development teams to execute on corporate goals
- Write and review technical documents including SOPs, batch records, test procedures, work instructions and summary reports
- Perform analytical testing using methods like flow cytometry, ddPCR and CFU assays during development and scale up runs
- Assist with the integrated process to transfer technology from the research and development programs to the clinical manufacturing facility. This includes performing the clinical production activities for the Sickle-cell disease program and maintaining training on site-specific SOPs and procedures
- Support regulatory strategy and activities, including authoring and review of CMC documentation for regulatory filings
- Co-ordinate with vendors as needed and manage inventory
- As required, design and monitor studies performed by selected outsourced vendors. Perform data analysis and prepare or review final report(s) for all such studies to ensure scientific integrity and compliance with regulatory requirements.
- Collaborate with Quality Assurance in conducting vendor compliance audits and preparing audit reports
What You Will Bring:
- A minimum of a Bachelor’s Degree in biology, pharmaceutical sciences, biotechnology or related field
- 4+ years’ experience in a related position in industry in the Cell and Gene therapy space
- Experience with CliniMACS cell isolations using the Plus and Prodigy as well as closed system manufacturing required
- Experience with process development and manufacturing relevant to cell and gene therapies preferred
- Experience with flow cytometry and PCR based assays preferred
- Process Development or GMP manufacturing experience for Cell and Gene therapy products
- Excellent teamwork and collaboration skills.
- Outstanding written and verbal communication skills.
- Strong 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.