Graphite Bio

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 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 and Manufacturing Associate will collaborate on the process design, development of strategic direction and support for all technical operations programs and processes. What You Will Do: Provide operational support for the development of processes for complex cell and gene therapies using gene-editing methods like CRISPR/Cas9 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 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 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 Coordinate with vendors as needed and manage inventory As required, design and monitor studies performed by selectedoutsourced vendors. Perform data analysis and prepare or review the 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 What You Will Bring: Bachelor's Degree in biology, pharmaceutical sciences, biotechnology or related field 3+ years' experience in a related position in a pharmaceutical or Biotech Company Experience with CliniMACS Prodigy cell isolations and closed system manufacturing preferred Experience with process development and manufacturing relevant to cell and gene therapies preferred Experience with flow cytometry and PCR based assays preferred: Experience with aseptic cell culture in a cGMP environment 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 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.

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.