Greg Adams
Angier
Summary
Dynamic Senior Director with extensive experience at FUJIFILM Diosynth Biotechnologies, driving regulatory CMC strategies and leading cross-functional teams. Expert in IND/BLA submissions and analytical method development, achieving successful FDA approvals. Proven ability to enhance service offerings and implement innovative technologies, fostering collaboration and delivering impactful results in biopharmaceutical programs.
Overview
32
32
years of professional experience
Work History
SENIOR DIRECTOR, GLOBAL ANALYTICAL STRATEGY
FUJIFILM Diosynth Biotechnologies
Morrisville
01.2017 - 06.2024
- Developed comprehensive CMC strategies for biopharmaceutical programs across preclinical to commercial phases
- Led the CMC regulatory strategy and authored critical sections for IND/BLA submissions
- Enhanced CMC service offerings and implemented innovative analytical technologies.
- Established global CMC standards and best practices across multi-site manufacturing network
- Provided technical leadership to cross-functional teams including process development, manufacturing, and regulatory
DIRECTOR, ANALYTICAL DEVELOPMENT
FUJIFILM Diosynth Biotechnologies
01.2007 - 01.2017
- Led CMC analytical strategy for recombinant protein programs from preclinical through commercialization
- Managed 50+ analytical scientists across multiple therapeutic modalities and development phases
- Authored and reviewed analytical sections for regulatory submissions supporting successful approvals
- Implemented analytical method lifecycle management supporting commercial manufacturing operations
- Coordinated with sponsors on CMC regulatory strategies, specifications, and submission timelines
SENIOR/STAFF SCIENTIST, ANALYTICAL DEVELOPMENT
FUJIFILM Diosynth Biotechnologies
01.1998 - 01.2007
- Led CMC development for FDA-approved immunotherapy program from IND through commercial launch
- Pioneered innovative mass spectrometry techniques for protein characterization and regulatory submissions
- Supported product development programs and multiple successful FDA approvals
Structural Analysis Group Manager
Bioreliance
01.1995 - 01.1998
Postdoctoral Research Chemist
UC San Francisco
01.1992 - 01.1995
Education
Ph.D. - Organic Chemistry
University of Adelaide
Australia01.1992
B.Sc. (Honors) - Organic Chemistry
University of Adelaide
Australia01.1987
Skills
- Regulatory CMC
- IND/BLA Strategy
- FDA Interactions
- CMC Writing
- Analytical Method Development
- Method Validation
- Process Characterization
- Technology Transfer
- Cross-Functional Leadership
- Program Management
- Recombinant Proteins
- Monoclonal Antibodies
- Viral Gene Therapies
- Mass Spectrometry
- Formulation Development
Accomplishments
- Supported 20+ successful IND submissions and multiple BLA approvals
- Contributed to FDA approval and launch of biopharmaceutical products
- Implemented cutting-edge analytical technologies improving CMC development processes
- Enhanced CMC capabilities contributing to analytical services growth
- Harmonized CMC practices across international manufacturing network
- Extensive FDA interactions including meetings, submissions, and regulatory correspondence
- Speaker at CMC conferences (CASSS, PDA, ISPE) and co-author of technical publications
Timeline
SENIOR DIRECTOR, GLOBAL ANALYTICAL STRATEGY
FUJIFILM Diosynth Biotechnologies
01.2017 - 06.2024
DIRECTOR, ANALYTICAL DEVELOPMENT
FUJIFILM Diosynth Biotechnologies
01.2007 - 01.2017
SENIOR/STAFF SCIENTIST, ANALYTICAL DEVELOPMENT
FUJIFILM Diosynth Biotechnologies
01.1998 - 01.2007
Structural Analysis Group Manager
Bioreliance
01.1995 - 01.1998
Postdoctoral Research Chemist
UC San Francisco
01.1992 - 01.1995
Ph.D. - Organic Chemistry
University of Adelaide
B.Sc. (Honors) - Organic Chemistry
University of Adelaide
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