Director

••••• ••••• IV BA, BS
MA, MBA, PhD (ABD)
•••••
Maple Glen, PA •••••
Home: ••••• Office: •••••
Cell: •••••

PROFILE

An extremely motivated and detail oriented individual with over fourteen years of experience in both the pharmaceutical and petrol-chemical industry. Expertise in the areas of project management, product development, quality systems and compliance with a demonstrated ability to manage multiple, complex tasks simultaneously. Recipient of Sunoco Standard of Leadership awards for leadership on new process controls for in-line blending. Recipient of awards of excellence in job performance within McNeil Consumer Health Care Areas of expertise include:

Project Management: Validation, DI/RO
water systems, packaging lines, liquid
fillers, and HVAC/BAS
Quality Systems (cGMP •••••CFR •••••, •••••, ISO •••••/•••••, QS•••••, ISO •••••,•••••, ISO •••••, ISO •••••, HACCP, NFPA, ICH Q7A)
Cross-functional collaboration with R&D,
Marketing, Procurement and Operations
Product Development and technology transfer from pilot to large scale reactors
•••••Sigma Tools (SPC, FEMA, DOE, DMAI2C, Root Cause Analysis, and MSA)
OSHA and EMSHA compliance
Technical and compliance training
•••••Sigma Master Black Belt, Lean Manufacturing, Kaizen Events and Predictive Indicator Tools
Regulatory audit experience with TSCA, FDA, DEA and DER/EPA
Johnson & Johnson certified external auditor ISO•••••/•••••, cGMP, HACCP,
Synthetic Organic Chemistry and Drug Design
Large scale blending and chemical reaction experience with lubricants, metal working fluids, specialty chemicals and pharmaceutical drug components.•••••Manufacturing of high volume aqueous and hydrocarbon based products

PROFESSIONAL EXPERIENCE

ALCAN GLOBAL PHARMACEUTICALS: ALCAN PACKAGING Bethlehem, PA (January •••••Present)
(Subsidiary of RioTinto-Alcan)
Director of Quality
Responsible for maintenance of FDA registration and compliance with •••••CFR•••••
Responsible for compliance with DEA Chapter ••••• and ARCOS reporting as importer and exporter of ClassII-IV controlled substances.
Responsible or the maintenance of ISO •••••/••••• and ISO •••••,••••• Environmental Certification.
Mentor and develop a staff of ••••• including salary, hourly, and temporary employees.
Review and approve high level company documentation such as supplier agreements, quality agreements and customer agreements as well.
Member of EHS program. Conduct monthly meetings pertaining to EHS issues as well as cGMP training for staff.
Participate and respond to customer audits. Some customer examples are GSK, J&J, Abbott, Barr Pharma, KOS Pharma, Cephalon, TEVA and others

McNEIL CONSUMER & SPECIALTY PHARMACEUTICALS, Ft. Washington, PA (May •••••December •••••)
(Subsidiary of Johnson & Johnson) OTC/RX
Manager of Quality Engineering
Reduced outside consulting fees by $•••••,••••• in ••••• and $•••••,••••• in •••••
Reduced calibration budget by •••••% ($•••••,•••••) per year on a •••••year contract in •••••
Review and approve all micro and QC lab OOS & OOT investigations.
Author and approve McNeil SOPS, CAPA and Regulatory Audit Reponses
SQM External Auditing for McNeil. Areas include: API, IPEC, CGMP and ISO•••••/•••••
Provide support for statistical analysis of filings for NDAs
Develop mathematical models for enhance compliance with CGMP stability programs (ICH)

INDEPENDENT QUALITY CONSULTANT, BP/CINA Naperville, IL and Exxon-Mobil Paulsboro, NJ (July ••••• May •••••)
Installed quality system in new lubes testing lab in Valero Refinery (ISO •••••)
Resolved aerospace product line quality issues. Developed molecular enhancements to avoid decomposition of products employed in aeronautics and space (NASA) applications for CINA,( Subsidiary of British Petroleum)

SUNOCO LUBRICANTS, Marcus Hook, PA (March •••••July •••••)
(Business unit acquired by Phillips•••••Union•••••)
Plant QA & QC Manager
Created a new mathematical blending model that reduced additive treat rate for lubricants. Reduced additive cost for Sunoco by $•••••,••••• per month. Annual savings of $••••• MM
Increased Right First Time for blending facility from •••••% to •••••% within 6 months.
Implemented and maintained ISO •••••, QS••••• and safety protocols within laboratory and production facility. Reduced lab expenses by 7%. Deployed and managed a budget of $••••• MM annually.
Negotiated grievances and scheduled work with members of the PACE/OCAW local. •••••

CASTROL INDUSTRIAL NORTH AMERICA (CINA), Warminster, PA (March •••••March •••••)
(Subsidiary of British Petroleum)
Product Development/Process Chemist
Developed novel gear oil and hydraulic additives projected to afford $••••• MM in projected annual sales for CINA.
Authored LVEs and Invention disclosure on 2 U.S. and 2 Global patents.
Improved manufacturing right first time for top selling additive for CINA from •••••% to •••••%.
Scale up of reaction technology and process trouble shooting in the Warminster plant
ISO and •••••sigma representative for Mayco business unit of CINA
Research and development with SPD and Castrol Automotive in Downers Grove, IL and Piscataway, NJ respectively.

ICI-ZENECA PHARMACEUTICALS (Rx CNS), Wilmington, DE (September•••••September •••••)
(Now ASTRA-ZENECA•••••
Senior Research Chemist
Research specialty in CNS disorders and chronic pain management.
Synthesized a drug candidate used to treat coronary occlusive stroke within the CNS division at Zeneca Pharmaceuticals. Wrote the synthesis and characterization protocols for US patent.
Developed methods for HPLC, IC, UV, ICP, IR, NMR, LC, XRF, GC, TLC, FAB, AA, and Mass Spec-GC.


EDUCATION

MBA Penn State University ••••• Business Management
PhD Temple University ••••• (ABD) Medicinal Chemistry
MA Temple University ••••• Organic Chemistry
Medical School Temple University: Audit of classes ••••• including cadaver dissection
BS Kings College ••••• ACS Certified in Chemistry
BA Kings College ••••• Biology Degree

PROFESIONAL TRAINING

Johnson & Johnson DMAI2C
Johnson & Johnson Root Cause Analysis
Johnson & Johnson Investigational Writing for the FDA
Johnson & Johnson Certified Green Belt Training
Johnson & Johnson Certificate in Design Excellence
Johnson & Johnson Certified External Auditor
Johnson & Johnson SAP Quality Module
Johnson & Johnson Lean Concepts
Johnson & Johnson Kaizen Event Planning and Execution
Sunoco SPC Excellence Training: Black Belt Training
CINA DOE (American Chemical Society Certified)
CINA Metal Working Fluid Formulation
CINA FEMA: Design and Process Protocols
ICI-Zeneca Organometallic Reagents and Recent Advancements

PUBLICATIONS, PATENTS & ACCOMPLISHMENTS

Patents and applications for invention disclosures:
Castrol Industrial North America: Inventor on (2) U.S. patent(s) and (2) E.U global patents for the preparation
of Organometallic Lubricants.
Zeneca Pharmaceuticals: Co-inventor on U.S. patent for the preparation of CNS drugs used to treat stroke.
Publications in the following Journals:
Journal of Organofluorine Chemistry
Journal of Organofluorine Chemistry
Journal of Organic Chemistry
Journal of Colloids & Surface
Chemical Engineering & News
Presentations:
ACS Poster at New Orleans meeting
STLE talk in Las Vegas: Corrosion inhibitors in metal Working Fluids
Teaching:
Adjunct faculty at Temple University for 4 years instructing Chemistry and Organic Chemistry courses
Adjunct faculty at Lehigh University for one semester instructing Organic Chemistry