Analytical Chemistry and Testing Expert

I can review data, prepare expert reports, and serve as a testifying expert. I can manage testing in contract research organizations developing sampling and testing protocols, siting work, and managing the programs. 

Areas of Expertise

 Analytical Chemistry including multidisciplinary problem solving, synthesizing data from organic and inorganic spectroscopy and spectrometry, chromatography, and product information, method development, validation, deformulation, characterization, and complex problem solving using solid and solution state one- and two-dimensional NMR, LC-NMR, FTIR, and optical and FTIR microscopy, HPLC, MS, Near-IR, UV-Vis, thermal analysis, on small molecule pharmaceuticals, peptides, excipients, polymers, and formulated drug products. 

 Pharmaceutical Development in CMC technical and regulatory expertise with extensive knowledge of the pharmaceutical CRO space, including capabilities, strengths and weaknesses of the players.  Managing external pharmaceutical development including pre-formulation, formulation, analytical, process development, and manufacturing at CROs and CMOs.  GMP regulations and laboratory compliance, including SOP development, documentation, OOS and out-of-trend investigations, CAPAs, and root cause analysis.

BUSINESS EXPERIENCE

Sr. Leader, Technical Solutions, Element Life Sciences 10/21-12/22, as a part of LS Leadership, working across the LS laboratories, providing technical solutions, harmonizing service offerings, and inspiring innovation. Reported to the VP of Life Sciences.

President/Chief Technical Officer (4/16-10/21), Sr. Vice President, Technical Services (1/15-3/16), Vice President, Chemical and Pharmaceutical Analysis, Avomeen Analytical Services (4/12 – 12/14), a premier analytical testing, problem solving, deformulation, and pharmaceutical development CRO.  Responsible for technical oversight of all projects and staff including business development, new service development, project management, and delivery.  Reports to CEO of Avomeen Analytical Services.

 Director, Expert Services and Structural Chemistry (3/11- 2/12), Director, Expert Services, Intertek – QTI  (8/10– 2/11), Head of Analytical Testing, North America (11/09 – 7/10), Intertek Expert Services (formerly Ciba Expert Services), a premier analytical testing and regulatory group focusing on food contact migration testing, extractables and leachables, REACH and TSCA registrations, method development and validations, and analytical problem solving.  Responsible for 1/3 of site laboratory operations and revenue.  Reported to Managing Director of Intertek-QTI.

Director of R&D, Velcera, Inc., Yardley, PA, a pre-revenue specialty company engaged in the development and licensing of pharmaceutical  products (8/07 -1/09)

Directed all new product development including sourcing, contract negotiation, protocol development, formulation, analytical and CMC development at domestic and international CROs and CMOs.  Also responsible for timelines, budgets, and ensuring appropriate quality and regulatory standards.       

 Manager and Project Director, Molecular Structure and Spectroscopy, 2004 to 7/2007, Manager, NMR Laboratory, Structural Chemistry, 2001 to 2003, Cardinal Health/Magellan Laboratories in RTP, NC, a $40MM CRO serving the pharmaceutical industry with analytical chemistry and product development services.

Responsible for P&L, strategic, quality, and operations for a $3.2MM business which served the pharmaceutical industry with qualification of analytical reference standards, isolation and identification of unknowns, quantitative assays, LC-MS, NMR, FTIR, UV, inorganic analysis, moisture and residual solvents analysis, thermal analysis, solid state characterization, method development and validations, and forensic problem solving on drug substances and formulated drug products, all under full cGMP compliance.  Consulted with customers, scoped and quoted work, developed and executed protocols, wrote and reviewed reports.  Managed 13 Ph.D. and B.S. chemists and reported to Sr. Director of Structural Chemistry.

Principal Scientist (2001), Senior Staff Scientist (1998 – 2000), Honeywell / AlliedSignal, a $30B diversified manufacturer of engineered plastics, fibers, specialty chemicals, specialty waxes, and equipment.

Responsible for the NMR and FTIR Laboratories that provided analytical support to Business Units and executing Six Sigma programs.  Reported to Manager of Analytical Sciences.

Analytical Chemist (1995 — 1997), DSM Copolymer, Inc., Baton Rouge, LA.

Led research program on structure of synthetic rubber resulting in 7 publications and a patent.

Postdoctoral Research Associate at University of Stuttgart, University of Leiden, and University of

California at Berkeley (1990 — 1995).

EDUCATION

Master's in Technology Management, Stevens Institute of Technology, May 2001.

Six Sigma Green Belt Certification, Honeywell, December 2000.

Ph.D., Chemical Physics, Department of Chemistry, M.I.T., February 1990.

B.S. with special honors, Major in Chemistry, The University of Chicago, June 1984.