Expertise



Expert and leader in R&D, process development and commercialization (manufacturing) of mammalian and microbial processes for production of biopharmaceuticals (API, MAbs, vaccines, therapeutic proteins, cell therapies, enzymes) & industrial biotech

Proven experience in setting up development and manufacturing centers of excellence in a global environment.

Expertise in:

Human health and animal health and the scientific and regulatory environment

Process development in industrial biotechnology.

Process robustness and reduction of variability ie Design for Manufacturing and DoE

Bioreactor development for microbial and mammalian cell culture.

Pilot plant design and management built to cGMP specifications- Projects greater than $6 million

Multiple biological products currently on market including the 1st Biosimilar Insulin (Tech Transfer and At Scale "Development"​ and commercial launch material

International process "development"​ consulting in biopharmaceuticals, vaccines, and industrial biotechnology - Process Improvements/Optimization and process robustness.

Global scientific and business development/relationship management.

Development and Integration of "new" technology into organizations.

External Manufacturing and development management

Improving product titers using small molecule additives while extending culture viability.

Creation of well plate-based cell culture assays for increasing the speed of testing and evaluating in vitro cell cultures and conditions.

Connecting MAb production enhancement to the biochemical network for specific productivity.

Laboratory and IT project management

International Project Management

CMO Management

Specialties

Technical management
Process Development
Scale-up and Scale down
Technology Transfers, DoE
Metabolic flux analysis
Kinetic modeling
Bioreactor development
Six Sigma- Master Black belt
Global Expertise- Europe and Asia
Ecoli, Yeast, Streptomyces, CHO, Vero
Cell therapeutics/stem cells