Expertise

• Specialize in the analytical in-process / laboratory problem resolution and cGMP auditing / compliance and gap analysis of pharmaceutical suppliers.
• Process analytical technology solutions and project management.
• Preparations for REACH compliance in the European Union (EU).
• Established a satellite pharmaceutical testing laboratory in Hyderabad, India.
• Pharmaceutical ingredient supplier (cGMP) auditing (ASQ-CQA) including quality systems and regulatory affairs.
• Qualification of Asian sunscreen suppliers resulting in full cGMP certification.
• Analytical and polymer chemistry.
• Construction of new laboratories and coordinating global organizations.
• Polymer characterization and analysis of unknown materials.
• Pyrrolidone chemistry.
• Raman spectroscopy.

Experience

Undisclosed Company, Independent Consultant, 2007 - Present

• Founder of a consulting firm, serving the chemical and pharmaceutical industries, specializing in, analytical in-process / laboratory problem resolution and cGMP auditing / compliance gap analysis of pharmaceutical and dietary supplement suppliers.
• Performed assessment of a laboratory and on-line analytical opportunities for increased efficiency and cost savings at a major inorganic chemicals manufacturing site with the use of an on-line Raman spectroscopy monitoring/control system.
• Performed several supplier cGMP compliance audits for a virtual pharmaceutical company client.
• Taught a USP educational session on new <467> Residual Solvents requirements as an invited instructor.
• Lead auditor of cGMP contract suppliers for a virtual OTC pharmaceutical company client; rigorously conducted audits led to correction of deficiencies and ensured strict compliance to 21CFR part211 drug product regulations.
• On an ongoing basis serving as lead auditor and surveillance document reviewer for the USP Verification Department; initial USP contract was renewed. In addition, appointed by the CEO of USP to serve on a newly formed pharmaceutical education advisory committee.
• Designed an at-line analytical strategy for a major food company to detect and quantify adulterants (such as melamine) in food ingredients.

Expert Witness

• For an intellectual property case involving proving polymer complexation in a consumer product; the well-conceived testing program developed resulted in a favorable out-of-court settlement for the client.
• In a customs law case involving the disproving of dumping of a foreign-made commodity chemical into the U.S. market.

GAF Corp. / International Specialty Products (ISP), Wayne, NJ, 1979 - 2007

Vice President, Analytical, Regulatory and Technical Information Services

• Reported to Senior VP, Operations, with dotted line reporting to CEO on regulatory matters.
• Responsible for staff of 40 and $10 million budget related to product quality and regulatory compliance.
• Enabled ISP to become the first company to receive the USP's quality seal under its new excipient verification program.
• Coordinated preparations for REACH compliance in the EU through development and organization of physico-chemical properties and toxicology data for substance preregistration.
• Supported sales of key products in Japan upon switch to GHS MSDS / label system by ensuring timely conformance.
• Developed active program to evaluate and qualify under GLP inexpensive toxicology CROs in India, with expected 50% savings for each study placed.
• Developed novel, rapid method for determination of residual vinyl pyrrolidone (a carcinogen) in personal care polymers via fast-GPC.
• Proved superiority of disintegrant product over competitor's, claimed identical counter type with respect to peroxide formation.

Analytical, 1988 - 2006

Vice President, QA and Product Stewardship, 2005 - 2006

• Managed 80 headquarters and plant staff and operating expense budget of $6 million plus an additional product stewardship programs budget of $3 million.
• Upon assuming responsibility of Product Stewardship Department, reorganized department into three distinct functions, and improved the functionality of the business steward model.
• Established program for qualification of Asian sunscreen API suppliers through third-party cGMP audits and re-audits with vendors gaining full cGMP certification and achieving 25% reduction in cost of raw materials.
• Established a satellite analytical testing laboratory in Hyderabad, India to supplement the project support work for headquarters Analytical Department; hired a manager and several chemists and constructed a state-of-the-art analytical laboratory in a shell building.

Senior Director, QA, and Technical Information Services, 2001 - 2005

• Led Quality Assurance for corporate office and principal manufacturing sites.
• Developed a program to gain certification to ISO9001:2000 quality standard, and achieved certification for corporate site and key manufacturing plants.
• Developed continuous improvement program based on a inter-site internal audit system.
• Resolved major, long-standing quality problems including burnt intrinsic particles in pharmaceutical disintegrants, odor in personal care polymers, and microbiological contamination in aqueous personal care polymers.
• Developed a novel pharmaceutical disintegrant with moderated release properties and lower hygroscopicity than crospovidone.
• Developed reliable ICP methodology to replace invalid USP concomitant visual comparison test for heavy metals in crospovidone and povidone excipients.
• Arranged for a Thomas A. Edison Patent Award for an ISP polymeric innovation to be awarded through the auspices of the Research and Development Council of NJ.
• Gained over $2 million of additional business and maintained several critical accounts through a series of technical presentations in Japan addressing customers' quality concerns.

Director, Analytical Department, 1988 - 2001

• Expanded the Analytical Department to its maximum size of 31 personnel.
• Reconstructed / re-energized department after a reduction-in-force.
• Established department Intranet site with rich content including a searchable guide to services.
• Established process-analytical cross-functional team to identify, evaluate, and implement on-line instrumental analyzers to control critical manufacturing operations.
• Developed a comprehensive competitive analysis program to monitor quality improvements and other significant changes in core chemistry products, particularly at a major competitor.
• Assumed additional responsibility for supervising the pharmaceutical, agricultural and beverage applications groups; restaffed these product development organizations.
• Developed metal-chelating form of crosslinked PVP (new composition-of-matter) for metal cation removal in aqueous systems.
• Developed a biodegradable form of PVP (new composition-of-matter) via the copolymerization of VP and 2-methylene-1,3-dioxepane.
• Developed technology to allow for incorporation of water-insoluble hair care polymers into an aqueous formulation through the use of microemulsions.
• Implemented the use of electronic nose technology to resolve key product odor complaints.
• Developed the novel use of pyrolysis GC/MS to determine the crosslinker identity and concentration in a crosslinked polymeric disintegrant and trace levels of soluble PVP in beer.

Phelps Dodge Cable & Wire Co., Research Chemist, Yonkers, NY, 1976 - 1979

Atmospheric Sciences Research Center, SUNY at Albany, NY, 1975 - 1976

New York University, Department of Chemistry, New York, NY, 1971 - 1975

• Research Assistant and Teaching Assistant

Honors & Publications

Academic and Professional Affiliations

• Awarded ASQ - Certified Quality Auditor (CQA) credential through the American Society for Quality (ASQ).
• IPEC (International Pharmaceutical Excipients Council).
• Executive Committee member - elected to a two-year term.
• Regulatory Affairs and Safety Committees - active member.
• Supported development of protocol for rapid acceptance of excipient materials into drug products.
• USP Excipient Verification Program advisory committee - invited member.
• American Chemistry Council (ACC) executive regulatory affairs (HPSP) team - ISP representative.
• New Jersey R&D Council - ISP representative.
• American Chemical Society, Analytical and Polymer Divisions member.
• Member of ChemPharma, ISPE, AAPS and ASQ.

Publications and Patents

• Awarded 10 U.S. patents (plus foreign filings).
• Authored 34 peer-reviewed papers and book chapters.
• Author a general chapter of the new USP/NF - good distribution practices of pharmaceutical excipients; served on that USP expert committee.

Education

• Ph.D. Physical Chemistry, New York University, NY
• M.S. Physical Chemistry, New York University, NY
• B.S. Chemistry, City College of New York, NY