Rick Soltero Email & Phone Number

Cary, Nc, Us

InstantGMP develops cloud-based electronic batch record software and Standard Operating Procedures that reinforce Good Manufacturing Practices. Ideal for cGMP manufacturing operations such as pharmaceutical, biotech, generic, OTC and dietary supplements. The only electronic batch record software for producing FDA regulated products that has GMP requirements baked into the automated workflows. Using the InstantGMP software and the InstantGMP Quality System can get you into GMP compliance easily and quickly.

Cary, Nc, Us

PharmaDirections is a leader in virtual drug development. We provide and direct the virtual teams of drug development experts who provide the intellectual oversight and the project management for all R&D activities. We provide the strategic development pathway and find rapid, economical pathways to INDs and NDAs. We also generate intellectual property for sponsors with repurposed drugs or with drugs whose composition of matter patents have expired. IP experience includes 21 patents and multiple invention disclosures in the areas of electronic quality and manufacturing systems, oral protein formulations, recombinant protein processes, drug delivery technologies and sustained release products.

Us

Biotech company focused on chemically modifying proteins and peptides to make them orally available. My responsibilities included directing Formulation Development, Chemical Development, GMP Manufacturing and Analytical Chemistry. In addition, I led the strategy and management of Nobex’ lead product, oral insulin, that resulted in a $283 MM licensing deal with GSK.

Managed multi-million dollar laboratory businesses including Analytical Chemistry, Method Development and Microbiology, Also responsible for Corporate Laboratory Training, Metrology, Computer Validation and Facilities. Responsible for implementing Laboratory Information Management system for Pharmacopeia testing.

Ca

Responsible for several multi-million dollar laboratory businesses with total revenue over $30M per year. Managed directly and indirectly 300 staff over 3 sites including 3 Analytical Chemistry laboratories as well as Biotechnology, Microbiology, Organic Synthesis and Peptide Synthesis laboratories. Also contributed to the formulation, submission and commercialization of nine generic drug products.

Brentford, Middlesex, Gb

Vice President level position responsible for global product development support • Led the trans-national integration of 100 scientists who provided analytical support for global research and development projects at research centers in the US and UK • Key player in changing the culture to be in full GMP compliance • Formed and led international project team that revamped the Laboratory Information Management System for a 15,000 person division

New Brunswick, Nj, Us

Responsible for protein analytical laboratory. Project Leader for development of Platelet Derived Growth Factor for treating dicubetis ulcers. Product is on the market at Regranex.

Managed 5 teams including Method Development and Validation, R&D stability, Preformulation, R&D Quality Control and Robotics. Project Manager for all pharmaceutical formulation development projects.

Various positions of increasing responsibility from clinical trial manufacturing to Senior Scientist in Pharmacy R&D. Conducted preformulation studies, biopharmaceutical studies and assessed in-vivo/in-vitro correlations of controlled release products. Manufactured clinical trial materials. Developed in-house Laboratory Information Management systems.

Ph.D., Physical Chemistry

M.S., Chemistry

B.S., Chemistry