HOME   

RESUME   

CONTACT  

EXPERIENCE
 

J M Pharmaceutical consulting, Inc.         2005-Present                                    
    President

Consultant to the pharmaceutical industry with expertise in chemical development; project management; technology evaluation, acquisition and transfer; outsourcing; business development; and regulatory/compliance issues (e.g. CMC filings, validation, audits, etc.).

• Assisted companies in reviewing development reports, validation protocols, and validation reports for compliance with FDA guidelines, including conducting a validation course for a client.
• Presented talks and was a course instructor on Technology Transfer.
• Recommended solutions to problems regarding synthesis, scale-up, and manufacturing procedures for traditional and biotech pharmaceutical companies, and evaluated/audited outsourcing alternatives.
• Reviewed regulatory documents for compliance with FDA commitments; and wrote SOP’s for a warehouse operation.
• Wrote report and gave a deposition as an expert witness in an anti-trust litigation lawsuit.

Lenoir-Rhyne University                                                               2008-Present

    Adjunct Professor of Chemistry

Taught Introductory Chemistry and associated laboratory course to first and second year undergraduate students.

 
Cedarburg Pharmaceuticals, Inc.             2000-2005                                         
    Vice President, Operations

 Responsible for the chemical R&D group, production staff and purchasing department that support projects from both our ethical and generic pharmaceutical customers.  This responsibility included participation on the executive management team involving company policies, strategy, and finances, preparation of proposals for new projects (65), and customer interaction on project/technical issues.

• Successfully completed 12 new projects, six of which were validated in our pilot plant or kilo lab facilities.  Three drug master files for generic customers were filed, one DMF was filed by our customer and two are in progress.  Two FDA pre-approval inspections were completed with no observations.
• Directly managed these projects and their costs using Microsoft Project and Excel., and was the primary customer contact on technical, product development and production issues 
• Expanded R&D staff and their capabilities, such as better on-line searching, analytical and development instrumentation (i.e. Argonaut Surveyor^®) for faster development of chemical processes.
• Organized the addition to our production facilities to expand our plant capacity, which included the hiring of additional staff.  Also managed the construction and staffing of a new high containment facility for a cytotoxic product, including validation and PAI inspection of this API.

 
PPG INDUSTRIES, INC.                                             1995-2000

            Commercial Development Manager, PPG-Sipsy           (1999-2000)

 Responsible for finding, evaluating, negotiating and coordinating new projects with the pharmaceutical industry; establishing contacts with emerging pharmaceutical companies; identifying and licensing new technologies; and assisting in the due diligence of custom manufacturing companies leading to an acquisition or partnership.

• Within four months, three projects have been identified with commercial potential of $25-50 MM at maturity.
• Initiated negotiating the license for a family of asymmetric catalysts, which will have potential in hydrogenation, hetero Diels-Alder reactions, etc.

Associate Director of R&D, Fine Chemicals                  (1995-1999)

 Directed twenty-one scientists in both the Fine Chemicals and Photochromic Production groups.  The Fine Chemical’s department was responsible for developing processes based on phosgene and chiral chemistries for our custom and pharmaceutical customers, and transferring this technology to our plants in Texas and Avrillé, France.  The Photochromic Production group developed, scaled up and produced sophisticated photochromic dyes in support of our Transitionsâ business unit.

• Provided leadership on both technical and business issues in building the custom pharmaceutical intermediates business to over $4MM in three years, which included improving our process development and technical transfer capability, project selection, CGMP implementation, strategy formulation, and presentations to the Executive Committee. 
• As part of combined PPG-Sipsy organization, new products have been developed in the U.S. since 1998, which will have sales of $15 MM in 2000.

SCIOS NOVA INC.           1989-1995            (merged with NOVA PHARMACEUTICAL CORPORATION - 1993)

  Director, Process Development, Analytical                   (1993-1995)
  Chemistry and Baltimore Facilities

Directed eight scientists in the process development and analytical chemistry groups with responsibility for supplying up to kilogram quantities of novel CNS and anti-inflammatory drugs for preclinical and clinical studies; and as Director assumed responsibility for the Baltimore Facilities Department.

• Supervised a $325,000 development project involving the large scale synthesis for our Bradykinin antagonist by a European contractor and directed the process group which improved the chiral synthetic procedures for the unnatural amino acids used in this peptide.  
  
• Directed the process development and kilo lab synthesis of 2 kg of a drug with three chiral centers for our EAA program CNS), including negotiating an agreement for a key bioconversion step with an outside manufacturer.

  Manager, Process Development and Analytical Chemistry       (1989-1993)

• Coordinated the establishment of a GMP facility, including writing SOP’s and batch records, hiring and training personnel, and developing analytical procedures and specifications for the manufacturer of an anti-cancer drug which included representing Nova during a successful FDA inspection.

JOHNSON & JOHNSON                                             1981-1989

            IMMUNOBIOLOGY RESEARCH INSTITUTE, Annandale, NJ

                        Assistant Director                                 (1989)

            ORTHO PHARMACEUTICAL CORPORATION, Raritan, NJ

                        Immunobiology Division

                        Research Manager                                (1985-1989)

                        Group Leader                                       (1982-1985)

                        Senior Scientist                                   (1981-1982)

Directed five scientists and coordinated international activities in the development of thymopentin, an immunoregulatory peptide with sales in excess of $100 million, and managed administrative and technical functions for the director within the Peptide Section.

• Organized and managed development of an 11-step synthesis of thymopentin and coordinated this project with J&J’s Swiss and Belgium affiliates, as well as outside suppliers, resulting in a 70% increase in overall reaction yield.
• Planned and managed $1.5 million construction project, including a new prep lab, hydrogenation facility, small pilot plant, and waste storage facility.

AMERICAN CYANAMID COMPANY                               1973-1981

          LEDERLE LABORATORIES

Seven years experience in the development of pharmaceutical synthetic processes and their successful transfer to the pilot plant and manufacturing departments.

EDUCATION 

Postdoctorate in Medicinal Chemistry, Ohio State University
Ph.D., Organic Chemistry, Ohio State University
B.S., Chemistry, Fordham University