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Phone: PHONE NUMBER AVAILABLEEmail: EMAIL AVAILABLEQA GMP Professional / Biochemist / Chemist / Technical Writer / InvestigatorSUMMARY OF EXPERIENCESTechnical WritingAuthored Quality Standards that included item descriptions, nomenclature, specifications, and analytical methods, Validation Protocols/Reports and Analytical Test Method Procedures that included explanations of the underlying scientific principles.Authored Project Summaries and more than 500 Investigation Reports with Root Cause Analysis and Corrective/Preventive Action remedies. Investigated nonconforming or atypical events with analytical methods, production processes, and QMS procedures.Executed Written and Verbal Presentations to senior management summarizing project progress as needed.Authored Business Plans for new products such as analytical instruments and specialty chemical product lines and Press Releases and Advertisements.PhD Thesis Biochemistry -SS Isozyme of HLADH - Developed a multi-step purification procedure for the steroid-active isozyme (one of nine) of horse liver alcohol dehydrogenase. Executed two-dimensional initial velocity kinetic studies in the presence and absence of inhibitors to determine the mechanism of action.MSc Thesis - Biochemistry AK I/HSDH I -Developed a targeted enzyme modification method to selectively incorporate cobalt into four of the allosteric enzyme's eight active sites inactivating one of the two enzyme functions to study how changes at one set of active sites were communicated to other set sites on the enzyme.MSc Thesis - Management Evaluated the use of survey questionnaires as tools for measuring the status of employee/management relations. Developed a survey questionnaire and wrote a software program to analyze the survey data to analyze the climate of an organization.Twelve Publications in scientific books and refereed journals and Nine Abstracts.MS Excel Applications - Developed spreadsheets for managing sample testing schedules, for tracking samples submitted to extramural contract testing labs, for monitoring stability sample pull dates, and for calculating project/time allocation.Established standards for technical report writing, formats for protocols and reports for assay validations and investigations; for monthly reports; and for project summaries/status updates to facilitate closure of OOS and OOT investigation reports and to reduce testing error rates.Quality Management SystemManaged Quality Control/R&D/ Analytical Services Laboratories. Designed lab space, critically evaluated instrument needs, and purchased and installed instruments to support an analytical method troubleshooting laboratory.Restructured the QC department along functional lines and authored job descriptions, description of responsibilities, and training modules to facilitate compliance with GMP training requirements.Established a Logbook Program to record the chronological history of instrument and equipment use and maintenance in a GMP compliant manner.Implemented standardized procedures for calibration expiry labeling of departmental equipment and instruments to reduce sticker clutter on GMP compliant equipment and instruments.InnovationManaged a $9MM high purity solvents business targeted for scientific and technical markets - Prepared and implemented business plans and developed financial models to support business projects.New Product Line Development - Successfully championed a new product line of high purity solvents packaged in returnable stainless steel containers (now marketed as Cycletainers) after demonstrating proof of concept and overcoming resistance from all departments in an organization accustomed to marketing specialty chemicals in one-way disposable containers.UV Vis Method for Production Process Control - Developed, and validated a UV Vis spectrophotometric assay for in-process addition of tocopherol (Vitamin E) for new product.NDIR TOC Instruments - Championed nondispersive infrared total organic carbon (TOC) instrumentation to eliminate atypical assay events that were occurring with conductivity based instruments.Color Determination by UV Vis - Championed the use of spectrophotometric instrumental methods for color determination based on application of the three dimensional CIE color space to eliminate the errors introduced by visual inspection.Time Out of Refrigeration Calculation Aid - Solved time-out-of-refrigeration calculation errors by championing the use of a specialized calculator and authoring a job aid for calculator operation. The calculators were informally named CasculatorsProblem ResolutionDetermined Root Cause of Bias in GC Assay Results - Mathematically determined that the root cause of low bias in several years of GC assay results for denatured alcohol raw material was due to a density mismatch between samples and standards. Re-designed the assay to eliminate the bias and restore accuracy.Determined Root Cause of apparent Excess Recovery of an Active During Surfactant Production - Successfully executed bench scale studies of the manufacturing process for a complex biopharmaceutical consisting of four water insoluble active ingredients including a peptide, a fatty acid, and two phospholipids and proved that apparent excess recovery of one of the actives was due to high bias in ELSD HPLC detection of the active ingredient.Determined Root Cause of UV Vis Colorimetric Test Variability - Identified sipper carryover as the root cause of excessive variability in results for two colorimetric UV Vis spectrophotometric assays. Defined mathematical equations to provide worst case estimates of the impact of sipper carryover on ten years of historical data.Resolved Low Bias Problem - RNASE T1 - Proved that the low bias in an assay for RNase T1 was due to the presence of an inhibitor in newer batched of RNA substrates. Revised the assay to include a pre-purification procedure for the RNA substrate restoring assay performance.Cell-Based Bioassay Validation Assay for Antibodies to Measles - Statistically demonstrated that validation attempts failed because precision acceptance criteria needed to be reset by applying propagation of uncertainty principles applied to assay performance data. When this was done the assay was successfully completed.Resolved Enzyme Assay Problems - Glucose Oxidase and Lactoperoxidase - Remediated the two assays by incorporating the use of a cuvette stirrer for assay execution. Taught chemists proper enzyme assay techniques remediating assay inaccuracy and lack of precision.Scientific WorkHPLC Applications Expert As a Field HPLC Applications Specialist served as a technical consultant solving customer problems with their HPLC instrumentation and methods - Demonstrated system configurations customized to meet specific customer needs - Conducted 2 and 3 day training seminars in chromatographic theory, HPLC methods development, trace analyte extraction, and proper HPLC system use and maintenance.Human Plasma Protein C (Anti- Clotting Protein) Purification Method for Selective Sequestration from Plasma by partitioning with a polyethylene glycol derivatized monoclonal antibody in Aqueous Two Phase Partitioning systems. Re-constructed an enzyme-labeled immunoassay (ELISA) for anti-blood clotting human plasma Protein C.Virus Studies - Bacteriophage T4 RNA Ligase (GP 63) GP63 functions as an RNA Ligase and as a small accessory protein that accelerated the attachment of the very large tails fibers to the base plate of the virus. Studied the effect of arginine on the conformation of the tail fibers relative to the virus body by ultracentrifugation sedimentation rate studiesAttempted to identify the structural points of tail fiber contact by selective immunoprecipitation and by developing site specific monoclonal antibodies.Forensic DNA Analysis - Executed restriction fragment length polymorphism (RFLP) typing of DNA using restriction enzyme digests, agarose gel electrophoresis, Southern blots, and chemiluminescence detection. Executed polymerase chain reaction (PCR) amplification of trace DNA samples and typed the DNA using a dot blot method.Medical Device Development - Supported the development of a Medical Device to volatilize a surfactant pharmaceutical used to treat premature blue babies to replace direct administration of a lung surfactant into blue babies by intubation. Completed regulatory medical device training to support clinical analyzers.Pharmaceutical Product Experience - Prescription and Over-the-Counter Pharmaceuticals and Raw Materials, Sterile Parenteral Pharmaceuticals, Complex Biopharmaceuticals (Vaccines and Blood Plasma Fractions), Dosage Forms (Liquids, Solids, Soft gels, Transdermal Patches, Surfactants, Suspensions), Prescription and OTC products, Medical DevicesComputer Competency - MS Word, Excel, Visio, PowerPoint, Access, Adobe, Atlas, Empower, SAP, EtQ, Trackwise, Minitab, VeevaEMPLOYMENTTakeda Pharma Co - Lexington, MA (Sunrise Systems Contractor)Jan 2022 to Nov 2022, Remote in Lancaster, PA (Project Completed)QUALITY CONTROL INVESTIGATOR IIIBiopharmaceutical ProductionRaw Materials Quality Control - Investigated atypical, non-conformance resultsCompendial testing FT-IR spectra for Glycine due to the presence of polymorphsFT-NIR instrument issues for spectra of production column packingsFT-Raman spectra for MES buffer saltsTitrimetric results for salts such a sodium bicarbonate, sodium carbonate and ammoniaResidue-on-ignition and loss-on-drying resultsSpecific gravity of alcohol digital density meter resultsMisplaced GMP recordsSpectrophotometric Bromine assay resultsSterility testingAuthored investigation reports. root cause analysis, hypothesis testing protocols, and Corrective and Preventive Actions (CAPA) plans.PPD Development (Ascent/ACS Solutions Contractor)Oct 2021 to Dec 2021, Remote in Lancaster, PA (Project Completed)SCIENTIFIC WRITERContract ManufacturingConverted SOPs from original legacy document formats to proposed new document formats in Veeva.Worked on converting an SOP for measuring cell deathAGC Biologics (Carlton National Contractor),Sep 2020 to Aug 2021, Remote in Lancaster, PA, (Project Completed)TECHNICAL WRITERContract Biopharmaceutical ManufacturingAuthored 300 raw Quality Standard specifications includingSingle-use, sterile assemblies used for biopharmaceutical production including detailed descriptions of all componentsSpecifications for raw materials such as culture media, chemicals, laboratory paraphernalia and personal safety accessories.Authored a training Power Point presentation for technical writing in the pharmaceutical industryUS Department of Commerce, Lancaster County, PAJuly 2020 Sep 2020 (Contract completed)ENUMERATORNational Census for 2020In-field, person-to-person follow-up assisting non-respondent residents to complete the 2020 Census questionnaireUsed iPhone in the field to enter data into Census enterprise computerHercon Pharmaceuticals, York, PAAugust 2019 (Training session completed)TECHNICAL WRITING INSTRUCTORDesigned and taught a two day training course in Technical Writing onsiteGSK Biologicals (Johnson Service Group Contractor), Marietta, PAJune 2018 to Oct 2018 (Project Completed)GMP COMPLIANCE SPECIALIST - TECHNICAL WRITERWarehouse OperationsVaccine Formulation, Filling, and LyophilizationWarehouse OperationsVaccine Formulation, Filling, and LyophilizationAuthored/revised Deviation Investigations, SOPs, Change Controls, and CAPAs using SAP-based documentation system Revised and updated twelve SOPsExecuted Staff Interviews, Batch Record Reviews, Historical Data Review/Analysis to investigate Out of Limit Process Reconciliation, Freezer Temperature Excursion, Document Format Error, Lost Documentation, Relative Humidity Probe Out of Tolerance EventsExecuted Root Cause Analysis methods, e.g., Five WhysSix Ms Root Cause AnalysisTime Line of Events Construction/AnalysisSPI Pharma, Lewes, DEOxford International ConsultantMar 2018 May 2018 (Project Completed)GMP REMEDIATION CHEMIST - LAB MANAGERAnalytical Method RemediationRestored a broken gas chromatograph to peak performanceOptimized GC system parameters to support a test method for glycols extracted from polyols.Designed and executed a validation procedure for the test method.Authored standard operating procedures for the glycol test method and for the operation of the HP6850 gas chromatograph with ChemStation software.Trained chemists in execution of the test method and in doing gas chromatographyLonza (Kelly Services Consultant), Rochester, NYJanuary 2017 May 2017 (Project Completed)QUALITY ASSURANCE GMP BIOCHEMIST CHEMISTAnalytical Method RemediationGMP Quality Management System remediation projectActive pharmaceutical ingredient manufacturing for over the counter productsExecuted nonconformance investigations and root cause analysisHands-on remediation, development, and validation of analytical methodsCreated readable written format for analytical methodsRewrote analytical test procedures with explanations of the underlying chemistryRemediated two enzyme activity assays and two gas chromatography methods improving accuracy and reproducibilityAuthored validation protocols and consequent reportsPharmaceutics International Inc. (Pii), Hunt Valley, MDApril 2016 October 2016 - (Left for more GMP compliant work environment)MANAGER QA INVESTIGATIONS - ANALYTICAL TESTING AND PRODUCTION PROCESSESProduction of Soft gels and Suspensions of Active IngredientsRemediation of regulatory agency observations of GMP gaps in soft gel manufacturing and analytical testingExecuted forty-one nonconformance investigations, root cause analyses, and risk assessments for laboratory and production GMP atypical events and gapsReviewed Batch Records to assess GMP complianceInvestigatedAtypically High Dissolution Results / Unknown HPLC Impurity Peaks / OOT Assay Results / OOS Particle Size Distribution Results / Chemist Testing Errors / Batch Record Process Deviations / Soft gel Manufacturing Processes / Facilities Environmental Monitoring System / Equipment Cleaning Processes / Automated Titration Instrument Problems / Non Compliance with Compendial SpecificationsEurofins Lancaster Laboratories, Lancaster, PASeptember 2014 April 2016 (Anticipated job elimination, function reassigned to group leaders)PRINCIPAL INVESTIGATOR NONCONFORMANCE EVENTSContract Testing Laboratories - USP/EP Compendial and Client Defined Test MethodsInvestigated GMP nonconformance and atypical events during contract compendial and noncompendial testing of raw materialsAuthored explanations of results provided to clientsInvestigation system management - Created a spreadsheet that successfully ensured 100% departmental completion record for investigations and CAPAsExecuted 120 investigations and root cause analyses with explanations of the underlying chemistryInvestigatedAutomated and Manual Titration Assays Colorimetric and Potentiometric Detection / Copper Sulfate Redox Methods / Acid-Base Titrations / Karl Fischer Moisture Analysis / Freezing Point Depression / Iodometric Titration Methods / Calculation errorsSiemens Healthcare Diagnostics (Infotree Contractor), Newark, DEJuly2014 to September 2014 - (Left for permanent position)ENGINEER IIIClinical Diagnostic Analyzer DevelopmentSupported a new clinical diagnostic analyzer projectAuthored fifty-seven quality standard vendor specifications for outsourced analyzer reagentsDesigned a cleaning validation protocol for a tube for reagent filling.McNeil Consumer Pharmaceuticals, Lancaster, PAJuly 2011 to June 2014 (Position eliminated due to Consent Decree reorganizationQC LAB MANAGER / DEVIATION INVESTIGATOR / PRINCIPAL SCIENTISTOver the Counter (OTC) Liquid and Tablet ManufacturingConsent Decree Activities - Reconstruction and remediation of Quality Management System deficiencies in CAPAs, Change Controls, SOPs, Annual Product Reviews, Quality Standards, monitoring out of trend conditions, stability program and stability data analysis, training program, product complaints under a Consent DecreeDEVIATION INVESTIGATORExecuted 150 Investigations and Root Cause AnalysesInvestigatedParticulates in Liquid Products and Purified Water / Specks on Tablet / OOS Tablet Press Material Reconciliation / Deviations from Filed TLC Product Test Method / Data Shifts in Product Assay Results / Determine Origin of Defects in Consumer Complaint Samples / Statistical Confirmation-Refutation of Apparent OOT Stability Results / Source of Unknown Peaks in HPLC Chromatograms / Stability Chamber Temperature ExcursionsQC LAB MANAGERManaged a QC department with 5 direct reports and a staff of 28 / Responsible for finished product, stability, and raw material testing, retention sample and stability sample management and stability data review.Restructured the lab organization to create a more stable lab environment / Redesigned laboratory space to maximize utilization / Assembled problem solving teams to reduce lab error rate by 50%Successfully championed the redesign of laboratory facilities and successfully maximized utilization of limited space for personnel and instrumentsPRINCIPAL SCIENTISTEvaluated new analytical technologies: Color determination by spectrophotometry / cleaning residue using alternate light sources / Inspection of equipment using fiber optic probes / Point person for contact with investigational testing contract labsPosition eliminated due to Consent Decree reorganization.GSK Biologicals (YOH Contractor), Marietta, PADec 2010 to Jun 2011 (Left for permanent position)QA OPERATIONS SPECIALIST PACKAGING AND VISUAL INSPECTIONPackaging/Visual Inspection of Vaccines in Syringes and VialsManual visual inspection and labeling/packaging operations for vaccine-filled vials and syringes.Prepared and issued production batch record documentsExecuted line clearancesAt line real time batch record review and AQL sampling / Post production batch record review and recording in SAP.MPI Research, State College, PAAug 2010 to Dec 2010 (Business future questionable)CGMP COMPLIANCE PROFESSIONALContract GMP and GLP Testing LaboratoriesReviewed protocols, methods, laboratory procedures, data and reports, processes and systems to determine the level of compliance with applicable current Good Manufacturing Practices (cGMP) Regulations, SOPs, guidance documents, methods, and study protocols.Authored a GMP training presentation and a draft of a Quality Manual.Conducted internal quality systems audits and for facilitated corrective actions.Noven Pharmaceuticals, Miami, FLNov 2009 to May 2010 - (Left to return to Pennsylvania)DIRECTOR QUALITY CONTROLPharmaceutical Transdermal Patch ProductionHands on management of 47 reports with four direct reports for a department supporting finished product, stability, and raw material testing, incoming sampling and inspection, retention sample management and data review.Increased department morale by establishing a stable work environment based on professional mutual respect and on empowerment of the individual.Developed and implemented a spreadsheet to facilitate test scheduling by supervisors, clarify work assignments to chemists, and provide a means to assess test execution metrics.Reduced sample turnaround time by 37% to 47% relative to previous year performance with no missed samples.Designed and implemented logbook programs for recording the chronological history of instrument use and maintenance.Redefined job descriptions and responsibilities and training modules for department positions.Established new standards for technical report writing to facilitate closure of OOS and OOT investigation reports in the Trackwise system.Talecris Biotherapeutics, Clayton, NCJul 2007 to Sep 2008 - (Left for more stable work environment)MANAGER QUALITY OPERATIONS ANALYTICAL SERVICESProduction of Pharmaceutical Products by Fractionation of Human PlasmaWorking manager for staff of fourteen of analytical support services in chemistry, biochemistry, environmental monitoring, and sample management in a GMP environmentResponsible for non-routine support functions in chemistry, biochemistry, environmental monitoring, and sample management in a GMP environment for human plasma fraction and protein products.Determined that the root cause of inaccurate results with an automated bioassay platform used for potency bioassays was the result of a difference in the transport mechanisms between reference standards and samples.Mathematically identified the root cause of low bias in GC assay results as the density mismatch between samples and standards and designed a corrected GC assay.Established standardized document formats / implemented a laboratory notebook system.Developed, qualified, validated, repaired, and transferred analytical/bioanalytical assays.Implemented a GMP compliant laboratory notebook system to fill a GMP documentation gap.Championed the use of spectrophotometric instrumental methods for color determination based on application of the three dimensional CIE color space to eliminate the errors introduced into color determination by visual inspection.Authored supporting documentation for analytical methods for IND and BLA submissions.Discovery Laboratories, Doylestown, PAJan 2006 to May 2007 - (Left due to uncertainty in earning FDA product approval)ASSOCIATE DIRECTOR - QUALITY CONTROL/ANALYTICAL SERVICESProduction of pharmaceutical surfactant to rescue blue babies - StartupManaged 11 chemists responsible for quality control and analytical services for active pharmaceutical ingredients, drug product, in-process samples, and raw materials using HPLC, GC, Karl Fischer moisture analysis, pH, instrumental color measurement, particle distribution, viscometry and surface tension.Developed and validated a new reverse phase HPLC-Corona CAD method for simultaneous analysis of chemically dissimilar actives and impurities (peptide, fatty acids, and phospholipids) replacing seven methods. Evaluated ELSD and Corona CAD detectors. Determined which detector would enable analysis of the actives/impurities in a single injection over the range of concentrations that would be encountered with the drug product.Managed the stability testing program and introduced SLIM stability management softwareCoordinated outside contractor testing lab activities.Designed new lab space and equipment requirements. Managed the installation of new stability chambers and HPLC systems.Reduced documentation error rate by 75% by re-training analysts to use a standardized technical report format.Successfully executed bench scale studies of the manufacturing process for a complex biopharmaceutical product and proved that the apparent yields exceeding 100% of one of the four active ingredients were due to an HPLC assay artifact with the evaporative light scattering detectorImproved instrument online status to more than 90% online from less than 50% by instituting procedures for anticipating preventative maintenance and establishing better communications with vendor service representatives.Merck & Co., Inc., West Point, PAOct 2000 to Dec 2005 (Position eliminated due to loss of Vioxx business)SENIOR PROJECT SCIENTISTGROUP LEADERSENIOR SCIENTISTLABORATORY TECHNICAL SUPPORTREGULATORY ANALYTICAL SERVICESVaccine and Parenteral Sterile Pharmaceutical Production(SENIOR PROJECT SCIENTIST - Laboratory Technical Support Chemistry)Supported over one hundred tests for vaccine and parenteral sterile pharmaceutical products including HPLC, GC, UV Vis, ICP-AES, TOC, KF Moisture analysis, TGA, osmometry, refractive index, conductivity, pH, Kjeldahl nitrogen, and Enzyme Activity Assays.Investigation of Nonconformances / Analytical Method Troubleshooting, Development, Validation, and Transfer / Writing Product Quality StandardsExecuted root cause investigations and developed corrective measures preventing product recalls and costly production delays.Key responsibility as technical Quality representative on assay transfer teams supporting new product initiatives.Technical expert during FDA auditsAnalyzed failed validation data and recommended remediation steps to save the validationsKey responsibility as technical Quality representative on assay transfer teams supporting new product initiatives.Executed root cause investigations and developed corrective measures preventing product recalls and costly production delays.Technical expert for supported assays during FDA audits.(GROUP LEADER - Laboratory Technical Support Chemistry)Working manager for 6 scientists responsible for analytical chemistry tests for vaccines and sterile small molecule pharmaceuticalsDesigned new lab space, critically evaluated instrument needs, and purchased and installed instruments.Mentored employees in career development plans and implemented performance reviews.Ensured staff was in compliance with SOP training requirements by organizing special training sessions and preparing training materials.(SENIOR PROJECT SCIENTIST - Regulatory Analytical Services)Revised/authored Quality Standards writing descriptions, specifications, and analytical methods for biological products and raw materials in precisely defined formats for the Quality Standard database library.Designed, developed, and validated a spectrophotometric assay for monitoring in-process addition of tocopherol that enabled successful completion of process development for a new product within extremely tight deadlines.Led a critical investigation that demonstrated that product vial closure integrity test failures were not true failures but the result of improper sample preparation thereby preventing a major product recall.Developed a statistically rugged qualification strategy to enable the introduction of newer moisture assay instrument models as replacements for older models, which were found not to be equivalent, by determining a bias factor that could be used when making accurate comparisons with historical data.Crompton & Knowles Colors Inc., Gibraltar, PAMar 1998 to Oct 2000 (Left anticipating closure of business in Pennsylvania)MANAGER QC/R&D ANALYTICAL SERVICESProduction of Dyes and Dye IntermediatesWorking manager with one direct reportQuality Control/R&D Analytical Services laboratory supporting research and manufacturing of organic synthesis of dyes and reaction intermediates.Maintained a throughput of over three hundred samples per month.Developed and applied analytical methods for dyes, intermediates, and auxiliaries using HPLC, FTIR, GC-FID, capillary electrophoresis, UV-Vis spectrophotometry and atomic absorption spectrometry.Developed HPLC analytical test methods for hundreds of dyes and dye intermediates built around three columns and three mobile phase systemsDiagnosed and solved customer problems with company products used in paper, textile, and ink applications.Successfully introduced analytical testing by capillary electrophoresis and attenuated total internal reflectance FT-IR.Pennsylvania State Police Crime Laboratory, Bethlehem, PAOct 1993 to Mar 1998 (Left for more research-oriented position)FORENSIC SCIENTIST IIIIdentified controlled drug substances using color tests, UV-Vis Spectrophotometry, FTIR, TLC, GC MS, and GC IR.Characterized genetic markers by serological methods using electrophoresis and enzyme assays.Performed restriction fragment length polymorphism (RFLP) typing of DNA using restriction enzyme digests, agarose gel electrophoresis, Southern blots, and chemiluminescence detection.Performed polymerase chain reaction (PCR) amplification of trace DNA samples and typed the DNA using a dot blot method.Provided expert testimony in court.Biphasics, Inc., Bethlehem, PAJun 1992 to Oct 1993 (Small business grant expired)RESEARCH SCIENTISTStartup based on Aqueous Two Phase Partitioning TechnologyPioneered the development of method to selectively sequester Protein C (a blood clotting inhibitor) from human plasma with a polyethylene glycol-derivatized monoclonal antibody in aqueous two phase partitioning systemsRe-constructed an enzyme-labeled immunoassay (ELISA) and plasma protein functional assay for anti-blood clotting Protein CAuthored grant proposals.EDUCATIONPhD BiochemistryRutgers University, New Brunswick, NJMSc BiochemistryRutgers University, New Brunswick, NJMSc ManagementCardinal Stritch College, Milwaukee, WIBA BiologyFranklin and Marshall College, Lancaster, PA |
