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Expert in Pharma Analytical Development, Stability, and QC Lab operations
Available for your Consulting and Expert Witness Needs
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Summary of Expertise:
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Listed with other top experts in: |
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Extensive use of various analytical techniques for qualitative and quantitative evaluation of small and large molecule compounds. Written many procedures describing in detail how the technique works and how it is to be used with various sample matrices.
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Developed and successfully used many analytical techniques to analyze a variety of different analytes. The analyte is the species under analysis.
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Expert has a Ph.D. in physical organic chemistry and 25 years of analytical development using various concepts encompasses by analytical chemistry. He has taught/trained analytical chemistry principles and the manner in which they integrate into procedures used for quantitative and qualitative analysis.
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Expert has hands-on experience and managed laboratories making use of the following analytical instruments: HPLC-UV, HPLC-Flour, HPLC-MS, UV-VIS spectrophotometer, FTIR, H-NMR, C-NMR, GC, HPTLC, AA, ICP, Near-IR, Titration, Karl Fischer Titrator, Powder X-Ray Diffraction, Elemental Analysis and most other instrumental techniques used to perform all tasks in the pharmaceutical analytical laboratory.
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Expert has used studies such as precision, accuracy, robustness, ruggedness, linearity, specificity, selectivity, etc. to ensure that the analytical method provides the required quality and technical soundness to yield information that is sufficient for the given task. In Pharmaceutical validation, ICH Q2A and ICH Q2B are international guidelines that descfribes the procedures and terminology for analytical method validation.
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Expert provides consulting for technical areas of product development, analytical R&D and Quality Control laboratories. Expert works with industry lab management to improve technical competancy, cGMP compliance and proper laboratory practices. Also serves as outsourcing interface between internal admin and CROs and CMOs. Expert also provides technical and compliance training to lab staff and senior management.
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Show Secondary and Basic Areas of Expertise | Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Chicago, Illinois;
Rockford, Illinois;
Aurora, Illinois;
Naperville, Illinois;
Joliet, Illinois;
Elgin, Illinois;
South Bend, Indiana;
Gary, Indiana;
Milwaukee, Wisconsin;
and Madison, Wisconsin.
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Degree |
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Subject |
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Institution |
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Honors |
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1983
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Ph.D.
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Physical Organic Chemistry
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New York University
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1980
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MS
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Organic-Analytical Chemistry
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NYU, NY
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1974
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BS
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Chemistry
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Univ. of Maryland, College Park
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Honors Thesis, Biochemistry
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Employer |
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Department |
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Title |
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Responsibilities |
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1998 to
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(Undisclosed Consulting Company)
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Principal Consultant
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Preside over consultancy serving technical areas of product development, analytical R&D and Quality Control laboratories. Expert works with industry lab management to improve technical competancy, cGMP compliance and proper laboratory practices. Also serves as outsourcing interface between internal admin and CROs and CMOs. Expert also provides technical and compliance training to lab staff and senior management.
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1994 to 1996
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SoloPak Pharmaceuticals, Inc.
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Product Development
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Director, Analytical and Formulation Development
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Successfully operated analytical development laboratories supporting product development. Prior to shutdown, conducted extensive product and process improvement to restore 5 major products to marketable status.
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1990 to 1995
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DuPont Merck Pharmaceuticals, INc.
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Multisource
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Assoc. Director of Analytical Development
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Established and successfully operated analytical R&D, Stability admin, and Testing and Tech. Services labs for new division of large proprietary drug manufacturer.
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1987 to 1990
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Barr Laboratories, Inc.
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Analytical R&D and Stability
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Director, Analytical R&D
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Enhanced and updated AR&D and Stability operations by strenghing staff technical capabilities, analytical documentation, instrumentation and introducing such lab automation concepts as robotics, chromatographic data systems and LIMS as well as required validation and qualification functions.
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1980 to 1987
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American Cyanamid
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Scientific Services, Stamford, CT and Pearl River, NY
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Senior Research Chemist
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Senior Analytical chemist providing general analytical services to internal clients at all sites (mostly Lederle Labs). Specialized in HPLC, GC and Lab auotmation techniques, but coordinated complex analytical projects with subject matter experts (NMR, FTIR, MS-MS, Microscopy, X-ray Diff./Fluor., Rheology and Thermal Analysis) to solve diverse problems.
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Associations/Societies
Expert is an active member of AAPS, ACS and PDA involved with various industry practices generating subcommittees.
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Professional Appointments
Member of editorial staff - LC/GC International Magazine, Chairman, Short Course Committee, AAPS, APQ Section.
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Awards/Recognition
DuPont Merck Excellence in Business Achievement Award, American Cyanamid product and Process Development Excellence Award,
At least 1-2 promotions to senior levels based on professional performance.
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Publications and Patents Summary
Expert has 15 papers in areas ranging from physical organic and kinetic mechanisms of pharmaceutical compounds, Investigation of Root Cause for Failing Stability Results, Proper Method development and Validation Practices, Cleaning Validation analytical method validation. He has written three chapters in three publications dealing with QC Lab Practices, Dealing with Laboratory and Manufacturing Deviations, and Validation of Chemical and Microbiological Analytical Methods for drug substances and drug products.
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Selected Publications and Publishers
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- DHI-PDA, Laboratory Validation - A Practitioners Guide
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- Compliance Handbook for Pharmaceuticals, Medical Devices and Biologics, Marcel Dekker Pubs.
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- Advanstar Pubs., Pharmaceutical Technology, Analytical Validation Supplement
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- Zymark Coirporation, Advances in Laboratory Automation
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- Chemical Communications
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| Selected Consulting Examples: |
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Resolution of complex analytical-organic problem which caused drug product to be recalled from market. Detected, elucidated structure and eliminated degradation product which caused precipitation in 2-mL vials of Hydralazine Hydrochloride (deg. product - oligomer derivative). Expertise in analytical chemistry, organic chemistry, purification techniques, mechanistic organic chemistry, HPLC trace method development and validation. Skilled use of 2-D NMR, FTIR, HPLC-MS and Powder X-Ray Diffraction.
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Audit or gap analysis of analytical development and QC labs for technical integrity/soundness and cGMP compliance. Development of remediation plan from observed deficiencies and along with client team, implement remediation plan to significantly enhance technical competancy, documentation and cGMP compliance of the various labs. Served as interim Director during remediation.
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Established from scratch and successfully operated analytical development, stability, tech services and QC lab for small generic and proprietary pharma firms. Entailed hiring of senior team, establishing documntation templates, purchasing equipment (IQ,OQ,PQ as well), training new personnel, establishing training programs, working with team to prepare all operartional and instrumental SOPs. Act as project mnager to ensure lab is functional and can pass FDA PAI and general cGMP inspection.
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Served as VP of R&D for virtual pharma firms. Coordinated all contract analytical, formulational, manufacturing activities with outside firms. Became directly involved in ensuring cGMP compliance or outsourced work and directly participated in RA-CMC preparation for ANDA and NDA submissions.
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Recent Client Requests:
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Usp validation expert.
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Methods validation expert for consulting on method validations for USP compendia procedures.
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Click the green button above to contact
Expert for a free initial screening call regarding your expert consulting needs.
Expert is available for consulting to corporate, legal and government clients.
Remember, your initial screening call to speak with
Expert is free.
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Click the green button above to contact
Expert for a free initial screening call regarding expert testimony,
litigation consulting and support, forensic services, or any related expert witness services.
A few litigation needs include product liability, personal injury, economic loss, intellectual property
(patent, trademark, trade secret, copyright), and insurance matters. Remember, your initial screening
call to speak with
Expert is free.
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| Language Skills: |
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| Foreign Language |
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Description |
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German
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Can speak and read fairly well.
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Participated in product selection committees for determinatin of target projects. Worked closely with marketing reps in the field to explain advantages of products in lay and technical terms during presentations.
Click the green button above to contact
Expert for a free initial screening call regarding your marketing research, industry research, and company
research needs. For research needs involving multiple experts or secondary research,
a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker
and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.
Remember, your initial screening call to speak with
Expert is free.
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| Additional Skills and Services: |
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Training/Seminars
Developed Quality Control Training Course given at client site (CD and verbal presentation).
Developed 12 presentations for AAPS, IIR and other symposia organizations dealing with OOS/OOT Deviation Investigation for QC and Stability Labs; Proper Validation of variety of analytical methods used for API and drug products; Proper establishment of API and drug product specifications, Proper establishment and operation of R&D and Commercial Stability Labs; Developent and validation of methods used for cleaning validation; Case studies in chracterization and structure elucidation of impurities and degradation products; Use of physico-chemical and molecular structural information to aid in development of HPLC methodology.
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Supplier and Vendor Location and Selection Proficient in the effective selection of API sources for formulation of various generic products (chemical, physical, microbiological as well as compliance of facilities). Worked extensively with instrumentation vendors in selection, design, installation and training of lab staff (along with IQ, OQ, PQ) and selection and implementation of lab data systems, LIMS, Robotics, Stability Tracking System and documentation databases along with computer validation activities.
Have extensively outsourced various analytical, process chemical, formulational and other development activfities with CROs, CMOs as well as RA/CMC consulting operations.
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Education
