Christian W Phillips
Proven and battle-tested senior leader with 25+ years of multidisciplinary experience in the life sciences driving late-stage development and commercialization of small molecules, biologics, and advanced modalities including cell and gene therapies. I thrive in fast paced, high stakes, dynamic environments, and leading organizational transformation to establish cGMP compliant operations, operational efficiency/stability, and robust fit-for-purpose quality systems. Having held VP level positions within CMC, Quality, Technical Operations and Manufacturing (sterile products) operating within both innovator and CDMO settings, I encompass a highly nuanced and integrated technical perspective that enables me to identify relevant risk factors and effective risk mitigation for sustainable compliance. I excel at boiling down otherwise complex multivariate processes and technical challenges into a common language and easy to understand operating principles that otherwise bridge knowledge gaps between the C-Suite and
Jurisdiction
United States
Notable Employer
- SVP, CMC and Quality at Inozyme Pharma
Experience
• Responsible for late stage development and commercialization of INZ-701 fusion protein (enzyme replacement therapy), Analytical Sciences, external manufacturing and supply chain as well as Quality Assurance and Compliance. • Successfully led the reorganization and consolidation of the Quality, Development, and Technical Operations functions following 25% reduction in force. Stabilized ongoing CMC operations while managing ongoing PPQ campaigns and adhering to aggressive BLA enabling timelines in the face of significant challenges; critically low clinical supply stores for global Phase III trials, intensive due diligence activity (pre BioMarin acquisition), and post-acquisition integration and knowledge transfer. • Established INZ-701 Integrated Control Strategy for drug substance and sterile lyophilized drug product to support BLA submission. • Responsible for product Quality, batch disposition, QC stability, specification development, vendor oversight and overall GMP/GCP compliance. • Led complete transformation of the Quality Unit and QMS to support Phase 3 development and commercial readiness, including Departure Systems (i.e, deviations, complaints, change control, CAPA), Supplier Qualification, External Audit Program, Batch Review and Disposition, Quality Manual, and several other key Policies and SOPs to enable GMP/GCP/GLP compliance. • Document Control: replaced legacy EDMS with complete migration and ‘go live’ to new system in 4 months. • Launched and led initiative to transfer sterile drug product operations from legacy European based CMO to domestic CMO to support PPQ resulting in $11M direct savings as well as a stabilized supply chain to meet current regulatory standards.
• Led process development and clinical manufacturing operations for autologous gene therapy program. • Built BioEngineering Lab and Pilot Plant for bioreactor cell suspensions. • Led scale-up and tech transfer to commercial manufacturing for several recombinant enzyme replacement therapies.