Senior Director, Head of Analytical Development and Quality Control

Graphite Bio is a clinical-stage biotechnology company focused on harnessing the power of targeted DNA integration. Integral Medicines 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

Summary: In this role you will set the strategies for developing state of-the-art analytical technologies and control systems to deliver Graphite's Gene Therapy products.

What You Will Do:

• Recruit and develop an expert team of analytical scientists to characterize quality gene therapy processes and products.
• Perform analytical method development and qualification, mechanism of action characterization and determination of critical quality attributes.
• Provide analytical support to research and process development in support of process characterization and validation
• Identify and understand the impact of product quality differences as the result of process changes to assure product comparability.
• Biological assay development (cell-based and non-cell based) in support of potency testing and product characterization, CQA assessment, process development support, comparability assessments, and potency method validation and product control system specifications.
• Validation and Testing: Perform clinical product QC release, stability testing, method qualification and execution of cGMP lab operations. Perform commercial method validation studies and assay transfers to QC partners internally and externally.
• Direct IND and BLA/MAA authoring and ensure the quality of development studies, reports and regulatory documents.
• Play a key role in regulatory negotiations.Develop , refine, and implement strategies, including Quality by Design concepts where appropriate, for product characterization, method development and validation, and specifications.
• 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 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 strongly preferred. Demonstrated leadership with strong communication skills and an ability to deliver the results through teamwork.
• High learning agility with demonstrated critical thinking and problem solving skills, ability to adapt under challenging situations.

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

contributor

Values-based leadership consistent with Graphite Bios' Core Values

Excitement about the vision and mission of Graphite Bio

Flexibility

Integrity

Compensation/ Benefits:

Competitive salary with equity

Free on-site gym access

Free on-site meals and coffee bar

Health benefits

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.