Rick Soltero

Rick Soltero Email and Phone Number

President of InstantGMP. Founder of PharmaDirections. @ InstantGMP, Inc.
Rick Soltero's Location
Cary, North Carolina, United States, United States
About Rick Soltero

President of InstantGMP, an electronic manufacturing execution system developed for manufacturing cGMP regulated products. InstantGMP PRO Is is a web-based, 21 CFR Part 11 compliant solution for biotech and pharmaceutical firms who want to improve their productivity, quality and margins. The electronic batch records software makes it easy for firms to use master production records and batch production records in a system that automatically enforces cGMP compliance.President of PharmaDirections, a virtual consulting and project management company that designs and manages preclinical, CMC and PK projects for pharma and biotech companies. PharmaDirections provides all of the expertise and infrastructure of a big pharma R&D group without their overhead. Our business model allows our clients to stay lean and focused and to work with an R&D team that provides economical, rapid and high quality research and development programs.

Rick Soltero's Current Company Details
InstantGMP, Inc.

Instantgmp, Inc.

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President of InstantGMP. Founder of PharmaDirections.
Rick Soltero Work Experience Details
  • Instantgmp, Inc.
    President
    Instantgmp, Inc. Jan 2004 - Present
    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.
  • Pharmadirections, Inc.
    President
    Pharmadirections, Inc. May 2003 - Present
    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.
  • Nobex Corporation
    Executive Director, Pharmaceutical And Analytical Development
    Nobex Corporation Aug 2000 - Mar 2003
    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.
  • Magellan Laboratories
    Vice President, Laboratory Operations
    Magellan Laboratories 1997 - 2000
    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.
  • Aai
    Vice President, Laboratory Operations
    Aai 1995 - 1997
    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.
  • Smithkline Beecham
    Worldwide Head Of R&D Group
    Smithkline Beecham 1993 - 1995
    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
  • Johnson & Johnson
    Section Head
    Johnson & Johnson 1991 - 1993
    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.
  • Berlax Laboratories
    Section Head
    Berlax Laboratories 1983 - 1990
    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.
  • Ciba-Geigy (Now Novartis)
    Senior Scientist
    Ciba-Geigy (Now Novartis) 1967 - 1983
    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.

Rick Soltero Skills

Drug Development Biotechnology Pharmaceutical Industry Gmp Clinical Development Fda Validation Technology Transfer Regulatory Affairs Biopharmaceuticals Clinical Trials Analytical Chemistry Hplc Pharmaceutics R&d Sop Life Sciences Commercialization Lifesciences Drug Delivery Formulation Strategy Drug Discovery Cro 21 Cfr Part 11 Manufacturing Glp Regulatory Submissions Ind Protein Chemistry Toxicology

Rick Soltero Education Details

  • Rutgers University - Newark
    Rutgers University - Newark
    Physical Chemistry
  • Rutgers University - Newark
    Rutgers University - Newark
    Chemistry
  • Ramapo College Of New Jersey
    Ramapo College Of New Jersey
    Chemistry

Frequently Asked Questions about Rick Soltero

What company does Rick Soltero work for?

Rick Soltero works for Instantgmp, Inc.

What is Rick Soltero's role at the current company?

Rick Soltero's current role is President of InstantGMP. Founder of PharmaDirections..

What is Rick Soltero's email address?

Rick Soltero's email address is rs****@****ons.com

What is Rick Soltero's direct phone number?

Rick Soltero's direct phone number is +191965*****

What schools did Rick Soltero attend?

Rick Soltero attended Rutgers University - Newark, Rutgers University - Newark, Ramapo College Of New Jersey.

What skills is Rick Soltero known for?

Rick Soltero has skills like Drug Development, Biotechnology, Pharmaceutical Industry, Gmp, Clinical Development, Fda, Validation, Technology Transfer, Regulatory Affairs, Biopharmaceuticals, Clinical Trials, Analytical Chemistry.

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