Senior Project Management Consultant
Mr. Blasingame has over 20 years of practical hands on experience in API drug substance manufacture. David has worked closely with the most API CMO’s in the US, Europe and Asia. David coordinates and leads manufacturing efforts by directly involving himself in all aspects of development and manufacture. This includes the research and development of small molecules, API synthetic routes and impurity control.
David contributed to the manufacturing tech transfer and commercial launch activities for the Kuvan Oral Powder and the Cerliponase Alfa products at BioMarin as well as Neratinib at Puma Biotechnology. David assists our clients with COGs, CMO selection and product transfers, validation and launch and can assume the role of project lead for CMC activities on behalf of a client.
In addition, he serves as a target subject matter expert in areas such as due-diligence, working with regulatory on commercial processes, or supported legal defending patents.
His current roles for clients include project management, review and generation of technical documentation, supplier identification, sourcing and the analysis of cost of goods. David applies phase appropriate strategy to all aspects of a products development. David’s technical competence and manufacturing background provides clients with an onsite decision-making capability to suit their needs.
- API Manufacturing
- Biologics Manufacturing
- Commercial Manufacturing
- Global Supply Chain
- CMO Tech Transfer
- Person in the Plant
- Clinical Supply
- Vendor Management
- Starting Materials