Expert in In-Process Analytical, cGMP Auditing, Polymer Characterization, Analytical Lab Design and Management
Expert supervised an industrial analytical research laboratory which possessed and successfully effectively deployed a wide variety of analytical technologies including chromatography (GC, GC/MS, HPLC, LC/MS, pyrolysis GC, ion chromatography, CE); spectroscopy (NMR, FT-IR, near-IR, UV-visible, ICP-OES); microscopy (optical, SEM, AFM); polymer characterization (GPC, viscometry, rheology, thermal analysis, physical testing, osmometry, light scattering photometry); and classical methods (titrations, gravimetry, colorimetry, pycnometry). Samples included polymers, surfactants, preservatives, sunscreens, emollients, various low molecular weight organics as well as complex mixtures and formulations.
In 1991, Expert established a process analytical cross-functional team at ISP to improve the consistency of key chemical processes, improve yield, reduce waste and pollution, and reduce in-process laboratory testing (and associated costs). A wide variety of successful projects were completed from 1991 to 2007 involving such technologies as near-IR spectroscopy (for vinylation reactions, polymerization reactions, and moisture in product dryers), viscometry, density meters, and gas chromatography. This effort long predated the PAT initiative enunciated by the FDA in 2004 as well as QbD (quality by design) and allowed ISP to maintain its position as a premier supplier of pharmaceutical excipients.
As chief quality officer for ISP from 2001 to 2006, Expert was responsible for ensuring the adherence to cGMP requirements for both pharmaceutical and cosmetic products. He was responsible for eliminating a major quality problem in an aqueous hair care polymer line, namely microbial contamination, through a radical overhaul of the incoming process water system. In addition, he led the cGMP qualification of new Asian suppliers of key sunscreen products to be resold by ISP into the U.S. and Canada (where sunscreens are considered to be drugs).
Expert's early career as a bench analytical chemist emphasized the analysis of polymeric materials. He is a recognized authority in the area of molecular weight measurement with respect to gel permeation chromatography (also known as size exclusion chromatography). He has a number of peer reviewed publications in this field including two chapters in the Marcel Dekker "Handbook of Size Exclusion Chromatography". Expert has also heavily used colligative property measurements (membrane and vapor phase osmometry) in his work as well as light scattering photometry and thermal analysis (differential scanning calorimetry and thermogravimetric analysis).
As chief quality officer for ISP from 2001 to 2006, Expert was responsible for ensuring the adherence to cGMP requirements for both pharmaceutical and cosmetic products. The standards for manufacturing pharmaceutical excipients at ISP were set to coincide with those at the highest level, namely active pharmaceutical ingredients, APIs, under 21 CFR part 211 and ICH Q7. In his consulting practice, Expert has continued to utilize his knowledge of API cGMP requirements to provide audit services for pharmaceutical firms wishing to monitor the degree of compliance of their suppliers or to qualify new suppliers. In 2007, he earned the American Society for Quality's Certified Quality Auditor credential.
Expert performed an assessment of laboratory and on-line analytical opportunities for increased efficiency and cost savings at a major inorganic chemicals manufacturing site. He uncovered a major opportunity to increase yield and reduce cost at the plant through the use of an on-line Raman spectroscopy monitoring/control system. Additionally, he provided insight to improve, consolidate and streamline QC laboratory operations through the elimination of (manually intensive) antiquated / unreliable tests with modern multitasking instruments. He has performed several supplier cGMP compliance audits for a virtual pharmaceutical company client. In so doing, he uncovered a number of major deficiencies the client was not aware of in the suppliers' operations. The resulting corrective actions prevented an adverse reaction from the FDA which could have potentially interfered with the client's business plan.
Expert may consult nationally and internationally, and is also local to the following cities: New York, New York - Yonkers, New York - Newark, New Jersey - Jersey City, New Jersey - Paterson, New Jersey - Elizabeth, New Jersey - Bridgeport, Connecticut - New Haven, Connecticut - Hartford, Connecticut - Philadelphia, Pennsylvania
|Year: 1970||Degree: B.S.||Subject: Chemistry||Institution: City College of New York|
|Year: 1973||Degree: M.S.||Subject: Physical Chemistry||Institution: New York University|
|Year: 1976||Degree: Ph.D.||Subject: Physical Chemistry||Institution: New York University|
|Years: 2007 to Present||Employer: Undisclosed||Title: President||Department:||Responsibilities: Established an independent consulting business serving the chemical and pharmaceutical industries in the areas of analytical in-process / laboratory problem resolution and cGMP auditing / compliance gap analysis of pharmaceutical suppliers, respectively.
Performed an assessment of laboratory and on-line analytical opportunities for increased efficiency and cost savings at a major inorganic chemicals manufacturing site; uncovered a major opportunity to increase yield and reduce cost at the plant through the use of an on-line Raman spectroscopy monitoring/control system.
Performed several supplier cGMP compliance audits for a virtual pharmaceutical company client; uncovered a number of major deficiencies the client was not aware of.
Earned the Certified Quality Auditor (CQA) credential through the American Society for Quality (ASQ).
|Years: 2001 to 2005||Employer: International Specialty Products (ISP)||Title: Senior Director||Department: Analytical, QA, and Technical Information Services||Responsibilities: 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 first-ever 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.
Gained over $2MM of additional business and maintained several critical accounts through a series of technical presentations in Japan addressing customers’ quality concerns.
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 R&D Council of NJ.
|Years: 1988 to 2001||Employer: ISP||Title: Director||Department: Analytical Department||Responsibilities: Expanded the Analytical Department to its maximum size of 31 personnel in 1998.
Reconstructed / reenergized the department after a 20% reduction-in-force in 1998.
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, resulting in many instances of improved efficiency, higher quality and improved safety.
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 as well as the concentration of trace levels of soluble PVP in beer.
|Years: 1983 to 1988||Employer: ISP||Title: Manager||Department: Analytical Section||Responsibilities: Reorganized section to align with three research functions - Separations and Spectroscopy, Polymer Characterization and Wet, Elemental and Microscopic Analysis.
Supervised 26 including 15 exempts and 8 Ph.D.s.
Consistently increased output of new/revised methods and reports with no staff additions.
Designed first GAF guide to the analytical section with keywords index to 550 methods.
Collaborated with MIS to implement first R&D LIMS.
|Years: 1976 to 1979||Employer: Phelps Dodge Cable & Wire Co.||Title: Research Chemist||Department:||Responsibilities: Expert supervised a small analytical R&D laboratory concerned with characterization of power and communication cable insulation materials.|
|Years: 1975 to 1976||Employer: SUNY at Albany||Title: Postdoctoral Research Associate||Department: Atmospheric Sciences Research Center||Responsibilities: He performed postdoctoral research studies relating to thermal storage of solar energy. Expert designed and constructed a DTA instrument which was used to measure and compare latent heat enthalpies of candidate materials.|
|Years: 1971 to 1975||Employer: New York University||Title: Research Assistant and Teaching Assistant||Department: Department of Chemistry||Responsibilities: Expert completed a two part doctoral dissertation. The first part dealt with phosphorescence studies of benzophenone in mixed hydroxylic low temperature glasses. The second part related to NMR studies of fused salts.|
|Years: 2008 to Present||Agency: United States Pharmacopeia||Role: Session Leader||Description: Expert led a breakout session on pharmaceutical excipients at a USP educational symposium on the new Residual Solvents <467> regulations (Feb 27, 2008)|
|Years||Country / Region||Summary|
|Years: 2001 to 2004||Country / Region: Japan||Summary: Expert made technical presentations on product quality and improvement plans, product physical chemistry and his company's quality management system to a number of Japanese customer companies as well as his company's Japanese headquarters. He resolved a major excipient degradation problem for one of these Japanese pharmaceutical customers.|
|Years: 2004 to 2006||Country / Region: India||Summary: He first traveled to India to select a technical manager for a planned satellite analytical R&D laboratory for his company in 2004. He returned in 2006 to select additional laboratory staff, perform a GMP audit of a potential pharmaceutical company acquisition, visit the new Indian USP laboratory, and perform a GLP audit on a proposed toxicology CRO.|
|Years: 1984 to 2006||Country / Region: Germany||Summary: Expert visited Germany on four occasions. The first visits related to his participation in a technical exchange on analytical and regulatory matters with a major Germany specialty chemical company. He also visited and established a relationship with the European Pharmacopoeia. He later visited several German facilities acquired by his company to review analytical and process chemistry issues.|
|Years: 2004 to 2004||Country / Region: United Kingdom||Summary: In his role of quality assurance head, Expert visited his company's European headquarters in London as well as chemical plants in southern England and Scotland to review analytical and process chemistry issues.|
|Associations / Societies|
|IPEC (International Pharmaceutical Excipients Council):
Regulatory Affairs and Safety Committees - active member;
Supported development of protocol for rapid acceptance of excipient materials into drug products.
Long term member of the American Chemical Society (ACS), Analytical and Polymer Divisions member.
Member of ChemPharma, ISPE, AAPS, ASQ as well as the Chemical Consultants Network.
|Licenses / Certifications|
|Awarded ASQ - Certified Quality Auditor (CQA) credential, effective December 1, 2007|
|IPEC: Executive Committee member - elected to a two-year term (2007-2008);
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.
|Publications and Patents Summary|
|Expert was awarded 10 U.S. patents (plus foreign filings) and authored 34 peer-reviewed papers and book chapters.|
|German||Expert's proficiency in German is conversational but not fluent.|
|Spanish||Expert's proficiency in Spanish is conversational but not fluent.|