Christopher Garten Email & Phone Number

Menlo Park, California, Us

Pittsburgh, Pa, Us

Executive leader responsible for the development of Quality systems, operations, and organizational culture, working across Cell & Gene Therapy TCR platforms.• Develop and implement quality strategies and plans for global Phase 1 TCR investigational product.• Develop and implement Quality Systems and Quality Operations for emerging R&D organization.• Drive organization to achieve a strong Quality culture. • Implement Supplier Quality program and manage supplier approvals for GMP and Clinical vendors. • Develop and maintain annual Quality budget. • Establish electronic laboratory data and controlled document systems

South San Francisco, California, Us

Senior leader of the Quality Assurance organization responsible for the build out of PACT Quality GxP organization and Quality Strategy for phase appropriate clinical GCP/GMP/GLP operations and TCR product registration for the US Market.

Durham, North Carolina, Us

Senior Leader of a start-up CDMO business focused on cell therapy product development and testing business. Product development platforms include NK cell and T cell therapies programs.

Houston, Texas, Us

Providing Quality Management Leadership for GMP/GLP functions in an emerging cell therapy/ biotech organization. Includes oversight of Quality Control, Quality Operations, and Quality Systems functions.

Houston, Texas, Us

Driving implmentation of quality systems to support early/late development and commercial cell therapy products for global distribution.

Melbourne, Vic, Au

Design and implement corporate quality systems for a Cell Therapies based development biopharmaceutical company in alignment with ICH Q8 and Q10. Manage quality systems and processes in operation. Oversight of corporate quality supplier program, controlled document process, corporate risk management, deviations, investigations and CAPA. Work across CMC, Clinical, and Preclinical to design flexible management reporting systems

Us

Provide direct oversight of quality assurance/control activities for drug products in clinical trials, study compliance with cGCP and corporate SOP’s, and commercialization. Responsible for development and implementation of sound quality strategies for the company’s oncology products. Oversight responsibilities include all GCP, GLP, GMP and quality assurance/control activities. As the Sr. Quality employee, ensure that all aspects of the quality program adds value to the Company’s mission to develop and commercialize ethical therapeutics.

Brentford, Middlesex, Gb

Responsible for the global implementation, tracking, change management, and reporting of R&D pharmaceutical development quality systems. Develop and deploy general and GMP training to operational lines and development teams. Green Belt Certified, Lean Sigma Line Champion.

Rahway, New Jersey, Us

Responsible for development and management of the R&D External CRO and Supplier GMP audit organization. Managed GMP external audit program with 6 direct reports. Approved and maintained approx. 200+ International and Domestic contract manufacturing, packaging, testing, distribution and excipient suppliers for the R&D US & EU GMP Clinical Supply Chain.

Us

Responsible for Laboratory Quality Assurance staff and Training Department supporting Analytical and BioAnalytical R&D departments including a total of 8 professionals and 2 manager direct reports.

Paris, France, Fr

Quality Assurance Project Manager for external contract development activities on R&D solid dosage, sterile formulation including aseptic fill, and biological clinical trial manufacturing and packaging. Responsible for contract manufacturing and packaging facility assessment, approval and oversight, including technology transfer and technical agreement development. Conduct Due Diligence and PreApproval Inspection readiness evaluation of contract facilities. Liaison with Regulatory Affairs and Clincal Project Teams to develop filing strategy.

Managed Quality Assurance for two commercial API manufacturing facilities (Wilmington, DE & Athens, GA) and one commercial Class III Medical Device manufacturing and packaging facility (Athens, GA), responsible for establishing and updating Corporate Quality Systems, policies, and audit programs, reporting to Executive Quality Assurance Director.

Certified Clinical Compliance Professional

Education record