PROFESSIONAL HIGHLIGHTS

Instrumental in setting up Pharmaceutical Development/Quality Control (PDQC) analytical laboratory in support of the Pilot Plant manufacturing facility for qualifications of critical utilities, routine monitoring, raw material and in-process testing.
Created and participated in a committee to align SOPs for general use across multiple functional areas within Centocor Pharmaceutical Development (May ’04 to April ‘10).

06-11 to present Confidential, Drexel Hill, PA 

Contracted as a Validation Engineer II to support the McNeil Consumer Healthcare’s Fort Washington, PA restart project in accordance with FDA Consent Decree requirements. Partnered with cross-functional team to develop and implement laboratory equipment/instrument qualification program. Responsible for drafting applicable validation documentation (VMP, VP, URS, FRS, DDS, IOQ, UAT, reports, SOPs, Qualification Discrepancies, etc.) utilizing Documentum. Execute applicable documentation for validation of Vitek 2 System, controlled temperature units (freezers, incubators, and refrigerators), glassware washers and autoclaves. Validate, Operate and Maintain GE Kaye Validator system for support of temperature mapping studies. Maintain project metrics and present to key stakeholders via status reports or meetings utilizing Sharepoint.

04-10 to 04-11 Confidential Huntingdon Valley, PA

Validation Specialist\\SME: Mar. 2011to Apr. 2011
Partnered with MedImmune, Inc. for the qualification and implementation of laboratory equipment (Freezers, Refrigerators, Incubators, etc.) utilizing GE Kaye Validator and associated software. Generated\\reviewed and executed applicable validation documentation (URS, FRS, DDS, IOQ, UAT, reports, SOPs, Qualification Discrepancies, etc.). 
Program Manger\\Validation Manager\\ SME: Apr. 2010 to Mar. 2011
Act as program manager to partner with JJPRD as point of contact and technical expert for the validation and implementation of analytical laboratory instruments. Responsible for the recruitment, training and management of a team of 4-8 employees. Increased efficiency and standardization of the scope and initiation of validation projects in adherence to internal SDLC practices\\procedures. Initiated and managed Change Controls\\Action Items\\CAPAs\\Deviations\\Event Investigations, etc utilizing Trackwise. Provide guidance, review and approval of applicable SDLC documentation (RA, change control, URS, FRS, DDS, IOPQ, UAT, reports, SOPs, forms, Qualification Discrepancies, etc.) for laboratory instruments and equipment utilizing Documentum. Maintained budget and project metrics and presented to key stakeholders via status reports or meetings utilizing Sharepoint.

02-03 to 04-10 Confidential Springhouse, PA 19477

Associate Scientist II\\Equipment Specialist: Mar. 2006 to Apr. 2010
Act as project manager to partner with vendors and cross-functional teams for the acquisition, validation and implementation of analytical laboratory instruments and equipment by managing and facilitating the Capital Acquisition Request (CAR), Change Control and validation processes in PD. Managed departmental capital budget including procurement and reconciliation of goods and services.

Defined scope and initiation of validation projects in adherence to internal SDLC practices\\procedures. Managed vendors in support of compliance and validation activities. Initiated and managed Change Controls\\Action Items\\CAPAs\\Deviations\\Event Investigations, etc utilizing Trackwise. Generated\\reviewed and executed applicable validation documentation (URS, FRS, DDS, IOQ, UAT, reports, SOPs) utilizing Documentum. Maintained project metrics and presented to key stakeholders via status reports or meetings utilizing Sharepoint.

Associate Scientist: Feb. 2005 to Mar 2006
Partner with vendors and cross-functional teams for the acquisition, validation and implementation of analytical laboratory instruments by managing and facilitating the Capital Acquisition Request (CAR), Change Control and validation processes in PDQC. Responsible for collecting quotations, drafting CARs, procuring and entering analytical laboratory instruments and equipment into Asset management database (Maximo), ensuring that applicable PM/Calibration tasks are scheduled and completed.

Develop applicable documentation (URS, FRS, DDS, IOQ, UAT, reports, SOPs) utilizing Documentum and execute applicable documents for validation studies. Provide training for newly validated systems. Initiate and manage Change Control, Validation, system maintenance\\calibration activities.

Associate Scientist: Feb. 2003 to Feb. 2005
Performed analytical testing with a full understanding of USP/NF and GMP requirements. Initiate and manage Change Controls. Participated in the review and execution of IQ/OQ/PQ/UAT’s (Documentum), method transfers and validations for analytical instruments and methods.

Daily tasks include maintenance of laboratory equipment (MP2\\Datastream, Maximo), set-up and organization of lab work stations, purchasing, receiving and inventory of supplies and reagents, SOP generation, revision and transfer. Interview and train laboratory personnel. Establish and coordinate lab workflow patterns and systems.

4-02 to 02-03 Confidential Springhouse, PA

Contracted through Kelly Scientific Resources in a Pharmaceutical Development/Quality Control (PDQC) analytical laboratory. Involved in the review and execution of IQ/OQ/PQ/UAT’s, method transfer and validations for the TOC analyzer, spectrofluorophotometer, and water testing (pH, Conductivity, EP and USP tests).

Daily tasks include maintenance of laboratory equipment, set-up and organization of lab work stations, purchasing, receiving and inventory of supplies and reagents, SOP generation, revision and transfer, and sample management.

4-01 to 4-02 Confidential Springhouse, PA

Contracted through Kelly Scientific Resources in a Quality Assurance/Quality Control laboratory. Conducted analytical testing on raw materials, intermediates and final products following USP/NF methods. Full understanding of USP/NF and GMP requirements along with proficiency with GC, spectroscopic methods, wet chemical techniques & Continuous Flow Analysis (CFA) analyses. Additional tasks included maintenance of chemical inventory, lab organization, and purified water sampling.

• TrackWise
• Documentum
• Asset Mangement Systems:
• MP2\\Data Stream
• Maximo
• Data Management Systems:
• ChemStore
• Empower
• CyberLab
• Sharepoint
• GE Kaye Labwatch
• GE Kaye Validator
• Beckman Coulter Array 360 Nephelometer
• OI Analytical Model 1010 TOC Analyzer
• Shimadzu RF-1501 Spectrofluorophotometer
• Varian Cary 100 UV/Vis Spectrophotometer
• Perkin Elmer LS55 Flourescence Spectrometer
• Brinkmann Karl Fischer Titrator w/ Tiamo 1.1
• Thermo Nicolet Avatar 370 FTIR
• Agilent HP1100 HPLC
• Convergent Bioscience ICE 280
• Bio Rad GS-800 Densitometer
• Spectramax M2 Plate Reader
• Dupont Qualicon Riboprinter
• Beckman Coulter PA800 cSDS
• Convergent Bioscience iCE280
• Perkin Elmer EnVision Plate Reader
• Applied Biosystem 7500 PCR
• Lonza ELx808 LAL system
• BD Bioscience FACSCANTO
• Innovatis Cedex Cell Counter
• MesoScale Discovery MSD Sector Imager
• GE Healthcare AKTA Explorer
• Waters AQCUITY UPLC
• GE Sievers 900 Lab TOC Analyzer

Confidential Bethlehem, PA
Bachelor of Science, Chemistry