David has 30+ years of extensive expertise in establishing the foundations of quality departments in multiple pharmaceutical and biotech companies.
CMC
Regulatory
Quality & Compliance
David Phillips has worked in a range of modalities (biologics/recombinant proteins/antibodies, ADCs, peptides, cell therapy, gene therapy programs, small molecules) as well as in both CDMOs and a number of sponsor companies. His experience has ranged from research/pre-IND to the different clinical development stages, and a number of commercial programs. David has been part of numerous inspections from a range of regulatory agencies globally, such as FDA, EMA and various European country agencies, MHRA, PDMA, ANVISA, ANMAT, TGA, Swissmedic, and others.
Prior to joining BioTechLogic and Dark Horse, David served as Senior Vice President, Head of Quality at VorBio where he built the quality management system from the ground up, spanning all GxP areas. He also served as Vice President, Head of Quality at Beam Therapeutics and at Kiniksa Pharmaceuticals where he established the quality foundation and overall strategic long-term vision for quality for both companies. Before Kiniksa, David was Vice President of Quality at Shire Pharmaceuticals prior to its acquisition by Takeda, where he held various quality roles through its growth and acquisition strategy. Notably, David was a core member of the team responsible for the integration of a number of programs and companies acquired by Shire and was responsible for various aspects quality product lifecycle planning, quality aspects of geographic expansion, and technical oversight of key quality functions (clinical and commercial) across a network of more than 25 locations. David was also responsible for Shire’s global testing network.
David’s experience working and living outside of the United States (a global role at Shire, with Lonza Biologics in Singapore, and at VaxGen, Inc./Celltrion in South Korea) provides him with a valuable global perspective. While at Lonza, he helped establish the country’s first biologics manufacturing park and collaborated with leading biopharmaceutical companies on large-scale biologics programs, as well as supported the cell therapy build for Lonza’s Singapore facility. David was also on the core startup and tech transfer team in establishing the first biologics facility in South Korea (Celltrion). David held numerous quality roles at VaxGen Inc., and Diosynth Biotechnology.
David holds a Master of Business Administration in new product development and project management and a Bachelor of Science in biochemistry and polymer chemistry, both from North Carolina State University.
David Phillips has worked in a range of modalities (biologics/recombinant proteins/antibodies, ADCs, peptides, cell therapy, gene therapy programs, small molecules) as well as in both CDMOs and a number of sponsor companies. His experience has ranged from research/pre-IND to the different clinical development stages, and a number of commercial programs. David has been part of numerous inspections from a range of regulatory agencies globally, such as FDA, EMA and various European country agencies, MHRA, PDMA, ANVISA, ANMAT, TGA, Swissmedic, and others.
Prior to joining BioTechLogic and Dark Horse, David served as Senior Vice President, Head of Quality at VorBio where he built the quality management system from the ground up, spanning all GxP areas. He also served as Vice President, Head of Quality at Beam Therapeutics and at Kiniksa Pharmaceuticals where he established the quality foundation and overall strategic long-term vision for quality for both companies. Before Kiniksa, David was Vice President of Quality at Shire Pharmaceuticals prior to its acquisition by Takeda, where he held various quality roles through its growth and acquisition strategy. Notably, David was a core member of the team responsible for the integration of a number of programs and companies acquired by Shire and was responsible for various aspects quality product lifecycle planning, quality aspects of geographic expansion, and technical oversight of key quality functions (clinical and commercial) across a network of more than 25 locations. David was also responsible for Shire’s global testing network.
David’s experience working and living outside of the United States (a global role at Shire, with Lonza Biologics in Singapore, and at VaxGen, Inc./Celltrion in South Korea) provides him with a valuable global perspective. While at Lonza, he helped establish the country’s first biologics manufacturing park and collaborated with leading biopharmaceutical companies on large-scale biologics programs, as well as supported the cell therapy build for Lonza’s Singapore facility. David was also on the core startup and tech transfer team in establishing the first biologics facility in South Korea (Celltrion). David held numerous quality roles at VaxGen Inc., and Diosynth Biotechnology.
David holds a Master of Business Administration in new product development and project management and a Bachelor of Science in biochemistry and polymer chemistry, both from North Carolina State University.