Sr Director of Analytical Development and QC
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
You will set the strategies and build the team for developing the state of–the–art analytical technologies and control systems to deliver Graphite’s Gene Therapy products.
What You Do:
- Collaborate with research and process development colleagues to develop core analytical testing capabilities for characterizing gene therapy products derived from stem cells. Perform analytical testing for manufacturing process characterization and validation
- Perform analytical method development and qualification, including mechanism of action and potency, characterization using genomic analysis and flow cytometry techniques, and determination of critical quality attributes (CQAs).
- Biological assay development (cell-based and non-cell based) in support of potency testing and product characterization, CQA assessment, process development, and comparability assessments.
- Validate QC methods and set product control system specifications.
- Work with CDMO partners to transfer analytical methods, monitor process and method performance, troubleshoot and perform continuous improvement.
- As company develops, responsibility will include clinical product QC testing, stability testing, method qualification, and execution of cGMP lab operations.
- Direct and prepare IND and BLA/MAA authoring and ensure the quality of development studies, reports, and regulatory documents.
- Play a key role in regulatory discussions.
- Identify and understand the impact of product quality differences as the result of process changes to assure product comparability.
- Develop, refine, and implement strategies, including Quality by Design concepts where appropriate, for product characterization, method development and validation, and specifications.
- Implement and adhere to internal and external (ICH, GMP) requirements for analytical functions, including training, investigations, validation, and QC testing
What You Will Bring:
- Ph.D. degree (preferably in Life Science) or equivalent work experience, and a minimum of 15 years of relevant experience in the pharmaceutical or biopharmaceutical industries, including 10 years of leadership experience, and demonstrated knowledge of relevant cGMP regulations.
- Experience with analytical development and QC of Cell and/or Gene Therapy products. Demonstrated leadership with strong communication skills and an ability to deliver results through teamwork.
- Able to attract and develop top technical talent and build strong teams.
- High learning agility with demonstrated critical thinking and problem-solving skills, ability to adapt to challenging situations
Fit with Graphite Bio's Culture
- Ability to build strong relationships with co-workers of various backgrounds and expertise.
- Teamwork and collaboration to achieve the company goals and objectives.
- Excitement about the vision and mission of Graphite Bio to deliver innovative therapies to patents.
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.