Pre-formulation, formulation, process development, scale-up, tech transfer, commercialization
Phase appropriate dosage forms for preclinical and clinical studies
Solubility enhancement technologies
Amorphous solid dispersions by spray-drying, hot-melt extrusion and complexation
Size-reduction and lipid-based systems
Oral modified release
Multiparticulate and osmotic delivery
Matrix tablets
Lipid modified release
Injectable drug delivery
Formulation development for solution and lyophilized vials for small molecules
IV and depot formulations
Powder-filled vials
Technology transfer
Focus Area
Commercial manufacturing
Credentials
Doctor of Philosophy in inorganic chemistry from Ohio University
Post-doctoral Fellow and Visiting Assistant Professor of chemistry at the University of Idaho
Master’s and Bachelor’s degrees in chemistry (polymer and materials) from Texas State University
Pre-formulation, formulation, process development, scale-up, tech transfer, and commercialization
Solubility enhancement technologies
Amorphous solid dispersions by spray-drying
Hot-melt extrusion
Size-reduction
Lipid-based systems
Complexation
Oral modified release
Multiparticulate delivery
Osmotic delivery
Taste masking
Fast-dissolving dosage forms
Lifecycle management
Designing novel drug delivery systems
Nano-milling
Process miniaturization
Process development and scale-up
Novel process design & implementation
Design of experiments
Technology transfer
Focus Area
Formulation and development
Credentials
Doctor of Philosophy in chemical engineering from the University of Colorado in Boulder
Bachelor’s degree in chemical engineering from the Indian Institute of Technology Madras (Chennai)
Characterized and model drying processes, unit operators
Fluid bed driers
One-pot granulators
Tablet coaters
Focus Area
Oral solid dose
Credentials
Doctor of Philosophy and Master’s degree in chemical engineering from Rutgers University
Bachelor’s degree in engineering, chemical engineering from The Cooper Union for the Advancement of Science & Art
Highly experienced in supply chain with a particular focus on sales and operations planning, transportation and logistics management, and system enhancements including SAP
Certified in production and inventory management (American Production and Inventory Control Society)
Multi-functional leadership experience in manufacturing, quality, and technical areas within pharmaceutical GMP environments
Focus Area
Logistics
Credentials
Bachelor’s degree in production and operations management from Ohio State
Highly experienced in the development of cell lines, media, and culture conditions for the production of recombinant proteins and naturalmetabolites, as well as bioreactor operation, scale-up, cGMP manufacturing and technology transfer
Research experience and skills include both mammalian cell culture and microbial fermentation (bacteria, yeast, filamentous fungi), process development, cellular physiology, and perfusion culture
Focus Area
Biologics (large molecule)
Credentials
Doctor of Philosophy in microbiology and molecular genetics from Rutgers University, NJ
Master of Science in microbiology and molecular genetics from Rutgers University, NJ
Bachelor of Science in biological sciences from Cook College, Rutgers University, NJ
Crystallization processes for commercial applications
Materials science expert
API development
Commercial manufacturing
Focus Area
API (small molecule)
Credentials
Doctor of Philosophy in synthetic organic chemistry from the University of Cambridge, U.K.
Bachelor’s degree in pure & applied chemistry from Strathclyde University in Glasgow, U.K.
Quality assurance experience including site auditing (domestic and international)
Pharmacy/pharmaceutical consultant services ad libitum
Focus Area
Softgels
Credentials
Pre-med/pharmacy degree from Indiana University South Bend, IN
Bachelor of Science, Pharmacy from Purdue University School of Pharmacy in West Lafayette, IN
Studied diabetes education and anticoagulation therapy
Immunization certified
Registered Pharmacist (R.Ph.)
Development of novel viral vector-based human gene therapies
Focus Area
Viral Vector Services
Credentials
Post-doctoral fellow at Johns Hopkins University School of Medicine
Doctor of Philosophy in microbiology from The State University of New York at Stony Brook
Bachelor’s degree in biology from Washington University in St. Louis
Manager of Regulatory Affairs, Microbial Manufacturing Services (MMS)
Scientific Expertise:
Regulatory strategy for marketing of controlled substances, new molecular entities, and new chemical entities
Regulatory intelligence and interpretation of regulatory guidance
Developing, editing, and reviewing regulatory submissions
Cell and gene therapy CMC expert
Microbiology and immunology
Viral pathogenesis
Medical technology
Central nervous system and oncology pharmaceuticals
Focus Area
Biologics
Credentials
Jean B. Kempner Postdoctoral Fellow and Ruth L. Kirschstein National Research Service Award Institutional Research Training Grant recipient, Doctor of Philosophy in Microbiology and Immunology from University of Texas Medical Branch, Bachelor of Science degree in Medical Technology from University of Texas MD Anderson Cancer Center School of Health Professions, Bachelor of Science degree in Biology from Texas A&M University Corpus Christi
Senior Director, Global Technical and Scientific Affairs
Scientific Expertise:
Product development
Small molecules
Pre-formulation, clinical development to lifecycle management
Scientific strategic planning/problem solving
Early development
Clinical supplies
Technology transfer
Supporting chemistry, manufacturing, and controls documentation
Focus Area
Formulation and development
Credentials
Doctor of Philosophy from the University of Bombay, India
Master of Business Administration from Richard Ivey School of Business, University of Western Ontario, Canada
Post Doctoral research at the University of Cincinnati
Microbial control, Product Quality microbiology, and Sterility Assurance for investigational new drug and marketing applications
Developing, editing and reviewing regulatory submissions, including reviews as a health authority assessor
Regulatory intelligence and interpreting regulatory guidance
Focus Area
Viral Vector Services
Credentials
Sallie Rosen Kaplan Post-Doctoral Fellow, National Cancer Institute, National Institutes of Health
Doctor of Philosophy in Microbiology and Molecular Genetics from Harvard University
Bachelor’s degree in Biochemistry and Molecular Biology from Michigan State University
Ultra-cold and cryogenic storage and biorepository
secondary packaging and labeling
Global cold chain logistics network operation
Supply chain visibility and real-time monitoring
Chain of identity and chain of custody
Focus Area
Advanced Therapies
Credentials
MBA from Northwestern University, Kellogg School of Management
MA in Biology from Smith College
BS in Biochemical Engineering from East China University of Science & Technology
Crystallization process development, small molecules and biological macromolecules
Particle engineering
Downstream processes (solid-liquid separation and drying)
Solid state chemistry and solid state analysis
Focus Area
API (small molecule)
Credentials
Habilitation (higher doctorate) in chemical engineering from MartinLuther-University Halle-Wittenberg, Halle (Saale), Germany
Doctor of Philosophy from the University of London, University College, U.K.