- 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.
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.
- 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.
- 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