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About Dr. Richard Soltero

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Richard Soltero, Ph.D. Career Summary

  • Executive level scientist with extensive experience in managing multi-site and multi-national pharmaceutical and biotechnology operations
  • Revenue responsibility up to $30M
  • Expert in pharmaceutical development and protein products with experience in ethical pharmaceuticals, biotechnology, consumer healthcare, contract research and software development
  • Focused on software development for GMP manufacturing
  • A process/results oriented team builder with strengths in strategic planning, and organizing and managing complex projects

PROFESSIONAL EXPERIENCE

InstantGMP, Inc., Cary, NC

President (2004-Present)

  • Founder and designer of an electronic batch record software system that reinforces Good Manufacturing Practices. Design and oversee development of new modules and enhancements. Manage customization projects from initial design through testing and deployment

PharmaDirections, Inc., Cary, NC

President (2003-Present)

  • Founder of a virtual drug development consulting firm. Manage contracts with biotech and pharmaceutical companies that need experienced scientific and management leadership. Organize and oversee multiple project teams who direct preclinical and pharmaceutical development programs for client companies

NOBEX Corporation, Research Triangle Park, NC

Executive Director, Pharmaceutical Development (2000 – 2003)

  • Directed Formulation Development, Chemical Development, GMP Manufacturing and Analytical Chemistry
  • Led the strategy and management of Nobex’s lead product, oral insulin, that resulted in a $283 MM licensing deal with GlaxoSmithKline
  • Formulated and patented proprietary liquid and solid oral dosage forms of therapeutic Provided human clinical trial products that were as good as the marketed injected product in one case and better than the marketed nasal product in another case
  • Patented recombinant protein and synthetic processes used to chemically modify proteins for oral delivery

MAGELLAN LABORATORIES, INC., Research Triangle Park, NC

Vice President, Laboratory Operations (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
  • Led the company’s strategic planning
  • Principle in design and up-fit of two laboratory buildings of 55,000 sq. each
  • Implemented Laboratory Information Management system for Pharmacopeial testing

AAI, Wilmington, NC

Vice President, Laboratory Operations (1995 – 1997)

  • Responsible for several multi-million-dollar laboratory businesses with total revenue over $30MM 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
  • Contributed to the formulation, submission and commercialization of nine generic drug
  • Led the turnaround and growth of a Biotechnology Services

SmithKlineBeecham Consumer Healthcare,  Parsippany,  NJ  and  Weybridge, England

Worldwide Head of Analytical, Microbiology and Stability R&D (1993 – 1995)

  • 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 the UK
  • Key player in changing the culture to be in full GMP
  • Formed  and   led   international   project   team   that   revamped   the   Laboratory Information Management System for a 15,000-person division.

ETHICON, Division of Johnson and Johnson, Somerville, NJ

Section Manager, Pharmaceutical Analysis (1991 – 1993)

  • Managed the development and validation of analytical methods for biotechnology products and surgical medicines.
  • Wrote SOPs to bring analytical department into GMP
  • Project Leader for interdisciplinary team that brought Platelet Derived Growth Factor for wound care to an IND in 10 months and successfully through Phase II (product is now on the market as Regranex).

Berlex Laboratories, Cedar Knolls, NJ

Section Head II, Pharmaceutical Analysis (1987 – 1990)

Section Head I, Pharmaceutical Analysis  (1983 – 1986)

  • Managed 5 teams including Method Development and Validation, R&D stability, Pre-Formulation, R&D Quality Control and Robotics
  • Project Manager for all pharmaceutical formulation development projects (approximately 12 programs on new chemical entities were run simultaneously).

CIBA-GEIGY, Suffern, NY and Summit NJ 

Various Positions (1967-1983)

  • Various positions of increasing responsibility from Formulation Development Technician to Senior Scientist in Pharmacy R&D
  • Conducted Pre-Formulation studies, biopharmaceutical studies and assessed in-vivo/in-vitro correlations of controlled release products
  • Integrated analytical equipment with computers
  • Wrote in-house Laboratory Information Management systems

EDUCATIONAL ACHIEVEMENTS

  • Ph.D. in Physical Chemistry from Rutgers University, Newark, NJ, 1982
  • M.S. in Physical Chemistry from Rutgers University, Newark, NJ, 1980
  • Completed all graduate work including Ph.D. thesis in 5 years while working full-time day job
  • B.S. in Chemistry from Ramapo College (NJ State College), Ramapo, NJ, 1976. (Graduated first in class)

SCIENTIFIC AND PROFESSIONAL ACTIVITIES

  • Scientific Reviewer  for  the  Journal of Biomedical and Pharmaceutical Analysis,  Analytical Chemistry, and Pharmaceutical Research
  • Member of Governing Board of the Eastern Analytical Symposium (EAS)
  • American Association of Pharmaceutical Scientists (AAPS)
  • Member of various national committees and organizer of many programs and symposia over 15 years
  • Founder of the Analytical and Pharmaceutical Quality Newsletter.  Editor-in-Chief from 1991 to 1994
  • Chair of the Eastern Regional AAPS Meeting, 1996. Chair of the Southeast Regional AAPS Meeting, 1998
  • Program Chair and General Chair of the NC Pharmaceutical Discussion Group, 2000, 2001
  • Member of USP Convention, 1995 –
  • Over 50 scientific publications and presentations in the areas of biopharmaceutics, protein product development and automation of manufacturing
  • 15 issued patents plus numerous invention disclosures in the areas of novel formulations, oral protein formulations, recombinant protein processes, health treatments, unique drug delivery systems and electronic manufacturing
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