Known as one of ‘Cellicon’s Valley’ hubs, I was hired to build the CCI’s GMP Manufacturing facility’s QA organization for the GMP Cell and Vaccine Manufacturing Facility. Responsible for integrating quality as part of the development, manufacture, testing, and release of cell and gene therapy products used for early Phase I and II clinical trials.

​

• Department Head managing the QMS, while ensuring manufactured products complied with applicable standards. 

• Streamline and optimize quality related activities in support of manufacture (such as batch records, materials management, change controls, document control, training, competency, etc.)

• Aid in the transfer of new product development activities into GMP clinical manufacture.

• Provide QA expertise to launch new clinical trials, including review of validation documents submitted to FDA, review and approval of CMCs, SOPs, Certificate of Analysis, specifications, acceptance criteria, analytical methods, etc.

• Ensured FACT accreditation was maintained by conducting frequent internal assessments to identify areas of risk and propose corrective and preventive actions.

• Liaised with IND sponsors, Regulatory, Clin Ops, Clinical Trial Unit, Principal Investigators, Medical Directors, etc., to convert a study concept into achievable deliverables.

• Work with biotech startups interested in using our GMP manufacturing facility, to review and approve Master Agreements and other related processes (i.e., Transfer, Material, Technology, Quality Agreements), SOWs, invoicing, budgets, etc.

• Worked supporting the launch of the first FDA approved CAR-T cell therapy, licensed to Novartis as Kymriah.

• Worked as dedicated QA support to drive the facility qualification and FDA licensing to allow the use of the GMP manufacturing facility.