Julie Eble, Ph.D.
President and CEO
Julie Eble, President, and CEO of Critical Path Services, LLC, is an analytical chemist with more than 30 years of experience in the pharmaceutical and crop protection industries. Her career in research provided Julie with invaluable insight into the workings of various regulatory agencies as well as the industry's perspective on product development and regulatory affairs. At Wyeth Laboratories, she developed methods and conducted stability and purity tests in the Product Development Section. She then conducted HPLC research and developed numerous analytical methods using HPLC and GC techniques for DuPont’s Biomedical Product Chromatography Application Group. After moving to Crop Protection at DuPont, Julie managed projects that ranged from planning and implementing phases of a business re-engineering to launching a worldwide program for project-management competency. She also served as Research Manager for the group accountable for tactical planning, resource management, contracting of technical studies, and implementation and use of Documentum, CoreDossier, and Artemis software. In addition, Julie was Study Director, Sponsor Representative, and Analytical Coordinator for GLP studies in the areas of fate, ecotoxicology, and residue chemistry.
Julie created Critical Path Services (CPS) in 2001 to support the growing demand for regulatory consulting services. Her extensive experience in both the pharmaceutical and crop protection industries has enabled her to bring a unique and successful blend of expertise to regulatory affairs. Her skill in gaining and retaining clients among new start-ups as well as global leaders reflects Julie’s depth of knowledge in multiple areas of the pharmaceutical and chemical research industries. Under her leadership, Critical Path Services has been instrumental in the successful planning, preparation, and submission of investigational and marketing applications to U.S. and international regulatory authorities on behalf of companies large and small.
Julie graduated from Villanova University with a Ph.D. in analytical chemistry. Her affiliations include membership in the American Chemical Society, Regulatory Affairs Professionals society, Crop Life of America, and the Drug Information Association.
Top
Evelyn Dugger, B.S.
Technical Writer/Instructor
Evelyn Dugger has focused her career in regulated scientific industries with over a decade in pharmaceutical companies. Her experience reaches from Research and Development to Human Resources as a Development and Training Manager to writing and editing documents for the Crop Protection regulatory industry. Evelyn brings to CPS her communication, organizational, problem solving, and leadership skills. She is utilizing these skills and more in her role as a Technical writer/editor and Account Manager for CPS.
Evelyn works primarily as a Summary Dossier Coordinator utilizing her organizational and leadership skills to manage the process of preparing the complex technical dossier documents necessary for crop protection regulatory submissions in Europe. This includes writing and editing summaries for studies in support of submissions.
Evelyn has extensive experience in the Pharmaceutical Industry. This experience includes bringing a start-up pharmaceutical companies’ development area into GLP/GMP compliance, maintaining a GLP laboratory, performing internal audits, writing SOPs, and supervising a group of technicians. In addition she has experience testing drug substance products and running the GLP laboratory in support of safety assessment.
Evelyn has also worked for W. L. Gore’s Industrial Division as an Application Engineer and New Product Development Engineer. She developed new chemistries for brine filtration, and new products for catalytic filtration as well as for batteries and capacitors. She also worked on global teams from Europe, China and Japan.
In addition, Evelyn has written, developed and managed training programs on Supervisory Development, Sexual Harassment, Oral Presentations, and Diversity. In addition, Evelyn worked with the University of Pennsylvania, Columbia University and the University of Delaware to bring courses to the employees to help them develop their careers.
She earned her B.S. in Chemistry from the University of Richmond.
Top
Jim Eble, B.S.
Business Manager/Technical Writer
Jim received his B.S. degree from Philadelphia University in Business Management and Marketing. He has worked for both public and private companies for the last 25 years. During this time Jim has managed large factories both domestically and internationally.
Most recently, Jim was the President and General Manager of a consumer products company based in New Jersey. In this position Jim had the overall responsibility of the company and directed the sales and marketing group.
Earlier Jim and his family were living and working in the UK and after this assignment he managed a large factory in Maryland. His has both administrative and sales experience.
Jim manages the legacy document program and performs document administrative work, in addition to sales, marketing and general business responsibilities.
Top
Joan Fletcher, A.A.S.
Technical Writer/CMC Specialist
Joan Fletcher brings 18 years of experience from the pharmaceutical industry to Critical Path Services, guiding our clients through the U.S. and international regulatory submission processes. Joan, a Dossier Coordinator at Critical Path Services, works with project teams to prepare complex, technical dossiers for regulatory submission to agencies worldwide. Her expertise includes management of projects involving cross-functional teams and addresses issues such as change control and electronic document publishing to achieve and maintain compliance with FDA quality system regulations.
Joan spent several years as a laboratory technician, testing drug substance and finished products. Then, after developing and implementing a sample-tracking system, Joan moved into Scientific Affairs at DuPont Pharmaceuticals / Bristol Myers Squibb Pharma. Here, her work focused on defining global Chemistry Manufacturing and Controls (CMC) registration strategies and developing the appropriate documentation. Joan’s CMC experience covers documents supporting NDAs, sNDAs, MAAs, NDSs, ANDAs, INDs, INDSs, and CTXs.
Joan graduated from Delaware Technical & Community College with an Associate Degree in applied science/bioscience.
Top
Kit Flynn, B.A.
Technical Writer
Kit Flynn began her career as a newspaper editor but now has more than 15 years experience as a technical writer in the agricultural and pharmaceutical R&D environments. Kit’s latest assignment for Critical Path Services was at DuPont Pharmaceuticals Company where she prepared synopses of clinical trials submitted to the FDA in support of a new drug application. She also contributed to a team supporting validation of a customized software application that stored clinical trial data.
Kit wrote user manuals and performance qualification (PQ) test scripts and participated in the validation testing of the software. She prepared validation summary documents, compiled training materials, and conducted selected training for the software.
Kit’s earlier work for Critical Path Services was in DuPont Crop Protection as an on-site writing consultant. She created report templates based on EPA and GLP requirements, wrote specific reports for submission to regulatory agencies, and organized and edited material for publication in peer-reviewed journals.
Kit earned her bachelor’s degree in English from the University of New Orleans.
Top
Mary Gutzat, B.S.
Technical Writer/Publisher
Mary Gutzat is a technical writer and electronic publisher for Critical Path Services with 10 years of experience in toxicology research and development, starting as a primary laboratory technician at DuPont’s Haskell Laboratories. This fast-paced, changing environment provided Mary with a diverse background in GLP-studies investigating the metabolism, genetic toxicology, and acute toxicology of pesticides, quantitative organic chemical analyses, and analytical studies involving permeation and penetration of chemicals through protective clothing. Subsequently, Mary worked as a coordinator, producing summaries of toxicological studies for submission to regulatory agencies, supervising a small group of writers, managing workflow, developing templates based on new regulations, and writing summaries and compiling them into the required format for submission.
Since she joined Critical Path Services, Mary has produced diverse documents for clients including study reports for submission to regulatory agencies, SOPs for conducting assays and using equipment, and summaries of toxicological studies for inclusion in submissions to regulatory agencies. Mary is proficient in Microsoft Word including mail merge, master documents, styles, document templates, and hidden text, and she uses CoreDossier and other tools for electronic publishing of various regulatory submissions.
Mary received her B.S. degree in biology from Indiana University of Pennsylvania.
Top
M. Jean Hornshuh, B.S.
Senior Research Scientist
Jean Hornshuh has 18 years of progressive analytical and residue chemistry experience from her career in product development at DuPont Crop Protection. Her career at DuPont started in the Method Development Group where, as a bench chemist, she focused on trace level analysis in complex matrices using HPLC with a variety of detection systems. Later, as leader of the Quality Assurance Unit, she handled special issues related to multi-site studies, which eventually became her responsibility.
Jean’s quality assurance background and her project management and analytical chemistry skills make her the ideal consultant for the various analytical studies handled by Critical Path Services. Her organizational skills and technical writing expertise qualify her as a primary internal resource for technical writing at both the study level and higher tier documents. Jean now is learning to apply her extensive qualifications to Chemistry Manufacturing and Controls (CMC) for pharmaceutical clients.
Jean earned a B.S. degree in food science and technology from Oregon State University and has done graduate work in food science at Michigan State University.
Top
Karen L'Empereur, Ph.D.
Senior Research Scientist
Karen L’Empereur has broad experience in trace level method development, including over a decade as a project manager and senior research scientist. This makes her a key member of the scientific consulting team at Critical Path Services.
Karen developed and validated numerous LC and GC analytical methods in various toxicological matrices during her post-doctoral work at DuPont’s Haskell Laboratory for Toxicological Studies. She also supervised the resources and planning for a 20-person analytical team.
Karen’s project management skills grew at DuPont Crop Protection while she was administrator of several analytical laboratories conducting a multi-year, large-scale groundwater study. She also acted as study director on multiple, remote, magnitude of residue studies and developed analytical methods using size exclusion chromatography in animal tissues.
Karen worked in forensic analytical chemistry before joining Critical Path Services. She assisted a qualified laboratory with its successful accreditation for its participation in the identification and analysis of chemical warfare weapons as governed by the Organization of Prohibition of Chemical Weapons. Karen was responsible for direct oversight of chemical warfare agent research projects including customer interaction, study design and processes, and determination / reconciliation of cost, timing, and deliverables.
Karen completed her doctoral work in analytical / natural products chemistry at Colorado State University.
Top
Craig Marshall, B.S.
Publisher/ Programmer
Craig Marshall is a Dossier Publisher for Critical Path Services. Craig’s corporate experience includes a decade as an associate scientist in the neurotoxicology group at DuPont’s Haskell Laboratories. Afterwards, he built his extensive Information Technology (IT) expertise from the ground up as a Senior Programmer Analyst for First USA Bank. In this capacity, he analyzed business requirements and created code to address these requirements using SQL, VB, and other programming tools.
At Critical Path Services, Craig compiles and publishes regulatory dossiers using CoreDossier. He applies his IT skills to simplify the processes and streamline the front-end tools associated with writing, managing, and publishing documents electronically for regulated industries.
Craig holds an A.A.S. in agriculture from the University of Delaware and a B.S. in computer science from Goldey-Beacom College.
Top
Susan Nicastro, B.A., MT (ASCP)
Technical Writer/QA Auditor
Susan Nicastro has almost a decade of pharmaceutical industry experience, specializing in technical support for all phases of clinical pathology testing required by SOPs, specific protocols, and GLP regulations. Sue began her career supporting the sales and marketing efforts for plastic blood collection tubes. At Terumo Medical Corporation, she purified monoclonal and polyclonal sera, gaining valuable experience with HPLC and SDS PAGE electrophoresis. Additionally, she prepared DNA probes and monoclonal antibody conjugates. Sue reinforced her laboratory expertise as an Associate Scientist for DuPont’s Haskell Laboratories and DuPont Pharmaceuticals / Bristol Myers Squibb Pharma in the Clinical Pathology Section.
Her background and her excellent attention to detail enable Sue to readily assume her duties at Critical Path Services as a technical writer and position her well in her training as a GLP Quality Assurance Auditor.
Sue holds a B.A. in biological sciences from the University of Delaware and is a Registered Medical Technologist.
Top
Mike Niedbalski, A.A.
Technical Writer/Technician
Mike Niedbalski has extensive analytical and documentation experience in pharmaceutical companies. Mike’s career began at SmithKline Beecham as a Control Analyst, performing tests on intermediate, bulk, and finished products in accordance with in-house standards and USP Compendia. This developed Mike’s knowledge of wet chemistry methods, titrimetric procedures, and gravimetric methods. Other analytical work involved HPLC, GC, and Apparatus 1 dissolution baths. A promotion to Document Coordinator gave Mike responsibility for the control and organization of files for decommissioning projects, and the tracking and scheduling of upcoming projects. Mike also wrote protocols for building equipment and machinery, monitored information flow among Administration, Logistics, Maintenance, Production, Quality Assurance, and Safety, and prepared management briefing information.
His regulatory document management skills increased at Colorcon where, as a Global Regulatory Affairs Assistant, he coordinated customer regulatory requests and maintained various regulatory databases used for monitoring purposes and as references when preparing both customer and internal regulatory documentation.
Before joining Critical Path Services, Mike worked as a QC chemist and team leader at Siegfried (USA), training chemists in wet chemistry and GC and LC techniques. Mike’s other responsibilities included reviewing laboratory notebooks and releasing data to production, initiating and writing Laboratory Investigation Reports and OOS / OOT Reports, and prioritizing laboratory samples to ensure their timely release.
Mike graduated from Gloucester County College with an A.A. in Business Administration and is pursuing a B.S. degree in Computer Science from Ellis College.
Top
Margaret E. Schmuckler, M.A.
Senior Research Scientist
Margaret Schmuckler is an independent consultant who works with Critical Path Services in the areas of product chemistry and environmental fate. She has 17 years of experience at DuPont, where she established the physical property program in EFATE in response to new and diverse global regulatory requirements. Margaret guided the organization, implementation, and supervision of in-house and contracted resources to satisfy all physical property regulatory criteria. In addition, she acted as Study Director, Sponsor Representative, and Annex II Dossier author and initiated the applicability of estimation methods using computational chemistry in preparation of position papers. Margaret also compiled and published a sulfonylurea herbicide vapor pressure paper and served as the Product Technical Expert for numerous active ingredients. She used structure activity correlation to predict fungicidal activity and developed a soil fungicide screen. Margaret was a member of several multidisciplinary teams in discovery research and implemented a vapor pressure estimation program regression analysis.
Margaret received her M.A. in chemistry with a major in biochemistry from Bryn Mawr College of Arts and Sciences.
Top
Barbara P. Smyser, Ph.D.
Senior Research Scientist
Barbara Smyser has 22 years of regulatory and research experience in environmental studies, biochemistry, and registration chemistry at three Fortune 500 companies. Barbara has headed technical teams in discovery research and in development. She has investigated bioaccumulation potential in mammalian tissues, field dissipation across various soil types, and isolation / identification of complex metabolites in plant and animal tissues. She also prepared scientific arguments / position papers and summarized higher tier documents.
Her strong scientific foundation qualifies Barbara for senior position in fate and metabolism issues at Critical Path Services, where she functions as GLP Study Director for numerous environmental fate and residue studies as well as technical project manager and writer for these studies. Additionally, she serves as Study Director and Study Monitor for various GLP studies on such species as rat, goat, and hen.
Barbara holds a Ph.D. in toxicology from North Carolina State University and a Master of Science degree in botany and plant pathology from the University of Maine.
Top
Marilyn A. Stadalius, Ph.D.
Business Development Manager/Senior Research Scientist
Marilyn Stadalius has extensive analytical chemistry experience in chromatography, including serving as President of Chromatography, Inc. In this capacity, Marilyn negotiated and then implemented an exclusive contract to provide technical support for the Hewlett-Packard (HP) and Agilent Technologies, Inc. ZORBAX HPLC product line. She successfully recruited and developed the national team required to handle the work for HP and Agilent, and exceeded all customer expectations. Her previous position, as General Manager and Marketing Support Manager for Mac-Mod Analytical, Inc., provided excellent preparation for this challenge.
Marilyn’s impressive list of qualifications includes technical project management for DuPont Crop Protection. This provided her with valuable “hands-on” experience as a Study Director, Sponsor Representative, and Analytical Coordinator for GLP studies in environmental fate, metabolism, and product chemistry. Before this, as part of DuPont’s Biomedical Product Chromatography Application Group, Marilyn resolved technical problems for customers and presented her personal research at national and international conferences.
Marilyn earned her Ph.D. in analytical chemistry at the University of Delaware.
Top
