Analytical Chemistry Consultant Specializing in Laboratory Problem Resolutions, Polymer Chemistry and cGMP Auditing

Technical Consultant #1505


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
Save Resume #1505
to Contact Form?

You must first click "Yes" to save this resume

Submit Request

You have no Saved Resumes

Add resumes within our various Ares of Expertise by clicking "Add Resume(s)" below.

Add Resume(s)