Working with clients, including the United States Food and Drug Administration (FDA), to provide training in, insight into, and analysis of the requirements of the drug CGMP statutes and regulations as well as their impacts and cost effective approaches to pro-active quality-based systems for compliance with said requirements.
Areas addressed include method/process development, validation, and manufacturing, and Electronic Records.Back to Credentials: Professional Experience
VP of QUALITY MANAGEMENT
Spearheaded the conversion of manufacturing systems from ad hoc into documented systems that complied with the strictures of ISO 9001:1994.
Generated requisite policy, SOP, work instruction and tool documents for the quality management and related functions.
Provided guidance to the other personnel.
Rewrote the Users Manual for their main product so that it actually matched that system's functionalities.Back to Credentials: Professional Experience
Worked with a variety of clients to solve their problems, develop and validate test methods and procedures, design robust processes, and improve their quality.
Audited proposals, systems, and suppliers as well as generated documents, methods, designs and systems as needed.Back to Credentials: Professional Experience
DIRECTOR OF QUALITY
To improve product quality, started the critical checking of data and effected production changes that upgraded product quality to meet Company and customer expectations.
Furnished the President of Nutro with detailed information on quality problems, their root causes and changes that could either eliminate the problem or reduce the risk of a recurrence.Back to Credentials: Professional Experience
DIRECTOR OF QUALITY CONTROL
In order to meet the expectations of the FDA, took charge of the development and validation of methods; reorganized operations; restructured lab audit and control procedures; and upgraded training and staff. [Note: The FDA's concerns were addressed.]
To address overcrowding and productivity, designed, equipped, and staffed two new laboratories within a $3MM budget to meet ISO/IEC Guide 25 (now, ISO 17025) competency standards.
Implemented systems for: acquisition, evaluation and archival of all data; qualification of instruments and analysts; demonstration of analyst/equipment suitability; and critical evaluation of results.
Overall, lab productivity more than doubled.Back to Credentials: Professional Experience
DIRECTOR LABORATORY QUALITY ASSURANCE
Oversaw the auditing of the Laboratory and implemented a validated LIMS system.
Developed and validated stability-indicating methods for various bulk pharmaceuticals using HPLC and cleaning methods using UV spectroscopy.
To speed the registration of Cephalexin, developed and validated a sub-ppm HPLC method for detecting possible penicillin contamination that was accepted by the FDA..
So that the drug product tested in a clinical trial could be produced reliably, developed a process, and the analytical controls, for the manufacture of the drug Sucralfate in China.
To speed the registration of Sucralfate, ascertained the structure of this organo-metallic chemical using solid-state NMR; and oversaw the writing and submission of a Type II DMF for the API.Back to Credentials: Professional Experience
MANAGER OF QUALITY CONTROL LABORATORY
Developed improved HPLC, GC, and titrimetric methods for ingredient testing.
Managed a Bulk Pharmaceutical Chemical Quality Laboratory that passed FDA Inspection and met the NJ DEP competency standards for the environmental testing it performed.Back to Credentials: Professional Experience
MANAGER OF LABORATORY OPERATIONS
Oversaw all aspects of both the company's laboratory operations and the activities of the contract laboratories that performed testing for the company.
Developed sampling system designs.Back to Credentials: Professional Experience
Led the reorganization of the laboratory that increase its productivity and raised its stature.
Developed and improved analytical methods in support of Schering AG's drug discovery efforts.
Developed improved operational protocols and test procedures that improved laboratory productivity and the quality of the result values reported.
Found novel HPLC separation approaches for chiral compounds and chiral mixtures that improved component separation and quantitation.Back to Credentials: Professional Experience
SENIOR RESEARCH SCIENTIST
Spearheaded International BASF Corporate Team that selected the Laboratory Information Management System (LIMS) vendor to be used by BASF worldwide.
Worked with German and Japanese scientists to evaluate and establish the ruggedness and utility of a key analytical method that I had developed.
Led Analytical Method Team that developed innovative methods for residue, impurity and actives for several biocides.
Installed state-of the-art gas distribution system for the laboratories.
Developed method for manufacturing acetamide HPLC columns that was critical for the analysis of the active and impurities in the herbicide POAST.Back to Credentials: Professional Experience
Developed analytical methods and techniques for a variety of research and approved biocides.
Discovered and developed an impurity method for the analysis of N-nitroso-amine impurities in chemical compounds that allowed the approximate ppm or ppb level to be measured even in cases where the exact structures of the impurities were not known.
Led team that redeveloped the process and analytical controls for a nitrated herbicide. [Note: Redeveloped process not only improved production safety but also increased manufacturing throughput and reduced costs.]
Supervised the successful overhaul of Puerto Rican laboratory operations for LEVAMISOL after the FDA had the facility red tagged in less than two (2) months lab operation was brought into compliance.
Developed modernized Phase Solubility purity methodology for AVENGE.
Led corporate committee on HPLC, and oversaw the critical evaluation of laboratory equipment.Back to Credentials: Professional Experience
PHYSICAL SCIENCE ASSISTANT MOS: 01F20
Worked as clinical chemist and phlebotomist at the hospital.
Improved the sample handling and the precision and reliability of several continuous-flow, air-segmented automated analysis systems.
on the Serviceman of the Quarter awards for the hospital and the post, Walter Reed Army Medical Center.
Rose in rank from E-1 to the first in my unit to be promoted to E-5 (Specialist 5) in less than 18 months.Back to Credentials: Professional Experience