Gary Vincent Barbera

* ****** ****

Somers Point, NJ

609-***-****

acwrlj@r.postjobfree.com

Summary

Skilled manager and chemist with 20+ years of solid-dosage development and pre-formulation experience using classical and non-classical instrumental analysis to develop generic and brand IR/ER tablets and capsules, suspensions, microsphere, and pellet formulations. Very experienced prescribing and interpreting the data from a wide array of wet chemistry and dry analysis instrumental techniques to characterize the API/in-process materials/finished product, monitor phase transformations, conduct reverse engineering experiments, and establish a stable, bio-equivalent formulation. HPLC/UV, FT-IR, Dissolution (I, II, IV, intrinsic), DSC, TGA, XRPD, moisture sorption-desorption, particle size, microscopy, SEM, surface area, and powder flow. Enjoys working with/within interdisciplinary teams, coaching and managing staff, and troubleshooting and solving technical challenges. Excellent oral/written communication skills, cGMP’s/GLP’s and successful track record of high performing teams.

Professional Experience

L.O. Thomas & Co.

Financial Advisor since 2008

Serve the investment needs of 35+ clients. Hold Series 7, 66, & Life and Health insurance licenses.

Par Pharmaceutical 2004 – 2008

Director Analytical Research and Development (2007-2008)

Directed a team of 17 chemists in a high throughput laboratory charged with HPLC method development and validation, IV/IVC dissolution, and comprehensive analytical support of experimental, in-process, and clinical batch release.

Successfully filed and received approval of 8 first-to-file ANDA’s in 2007. (paragraph IV certification/design around/time release formulations)

Personally selected to a specialized due diligence team to inspect facilities, conduct technical audits, and report findings to senior management staff on potential licensing candidates.

Developed an effective matrix organization and coached managers on decision making, project priorities, and team building to provide customers with rapid sample turnaround and fast problem resolution.

Introduced new technology to the company including LALLS (low angle laser light scattering), size exclusion chromatography, and capillary zone electrophoresis for the characterization and release of a polysaccharide compound.

Director Pre-formulation (2004-2007)

Designed a pre-formulation laboratory, hired staff, and outfitted the lab with 15 cGMP qualified instruments for conducting pre-formulation studies within a year.

Established new reverse engineering techniques and methods to drive timely and robust formulation development.

Initiated and developed relationships with external departments (QC, QA, off-site manufacturing operations) to streamline manufacturing investigations, reduce outside testing costs, and eliminate backlogs.

Sandoz Pharmaceutical 2001 - 2004

Principal Scientist (2001-2004)

Led team of four Ph.D. analytical chemists responsible for comprehensive pre-formulation studies, development and validation of physical characterization methods/polymorphs, and evaluation of vendor raw materials. Typical workload of 15-20+ new products annually.

Wrote reports, presented data, and made recommendations based on the physico-chemical characterization data.

Applied a broad array of instrumental techniques to thoroughly characterize investigational compounds including: HPLC (assay and impurity determination), UV, Karl Fisher, pKa/log P, solubility, pH stability, drug-excipient compatibility, mass-spec, FT-IR, DSC, TGA, XRPD, particle size, moisture-sorption, microscopy, powder flow determinations, and surface area analysis.

Developed and validated particle size test methods, quantitative polymorph test methods, established specifications and physical test methods for 15-20+ raw materials and finished products annually.

Purdue-Pharma 1998 – 2001

Principal Scientist

Prescribed, diagnosed, and conducted physico-chemical characterization analysis on existing, line extension, and investigational drugs using XRD/VT-XRD, DSC, TGA, FT-IR, moisture sorption-desorption, automated pKa/log P determinations, intrinsic dissolution, and solubility measurements.

Collaborated with formulation scientists and chemical process manufacturing scientists and performed characterization of process development batches of oxycodone HCl, microsphere formulations, tamper proof oxycodone HCl/naltrexone HCl formulations.

Installed, validated and established operational procedures for two moisture-sorption-desorption apparatus, automated log P/pKa device, an automated solubility determination instrument, X-ray powder diffractometer, two DSC’s, a TGA, two particle size analyzers, and a surface area instrument.

Evaluated technology and wrote reports for management: dielectric analysis (DEA), thermo-mechanical analysis (TMA), and thermally stimulated current (TSC).

Schein Pharmaceutical 1993 – 1997

Manager Pre-formulation (1994-1997)

Managed a team of four research scientists charged with comprehensive pre-formulation studies, method development, assay/impurity analysis, and dissolution testing of developmental formulations.

Conducted reverse engineering on competitor products to determine pivotal composition of ingredients and physical attributes in order to improve the probability of successful bio-equivalent time-release formulations.

Developed and validated quantitative polymorph determination methods. In a specific instance, developed and validated an FT-IR test method for detecting 0.2% of ranitidine form II in form I using a mineral oil mull dispersion spread on KBr plates.

Developed and validated appropriate physical test methods for inclusion in the raw material monograph and in-process batch manufacturing records.

Bristol-Myers Squibb 1988 – 1992

Scientist (1988-1992)

Learned and developed proficiency with XRPD, DSC, TGA, particle size, surface area, and microscopy.

Led investigations and conducted polymorph characterization studies, polymorph screening studies, and polymorph phase transformation studies to identify potential polymorphic forms/hydrates/solvates and stable forms.

Education

B.S. Biology Rutgers, 1988.

Patents

Barbera, Gary; Doshi, Chetan Chhabildas; Patel, Mahendra R.; Davila, Pablo; Patel, Satishkumar Ambalal. 2011. Solubility of hydrophobic drugs with a compound having a carboxylic acid moiety. U.S. Patent 7939104, Filed February 15, 2008, and issued May 10, 2011.

Sadatrezaei, Mohsen; Davila, Pablo; Barbera, Gary. 2008. Stabilized azithromycin composition. Patent application 200********. Filed July 27, 2007.

Patel, Ashish; Barbera, Gary. 2005. Modafinil compositions. Application 200********. Patent application Filed December 22, 2003.

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