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Title Project Management Technology Transfer
Target Location US-PA-Allentown
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Candidate's Name , BSAllentown, PALINKEDIN LINK AVAILABLEEMAIL AVAILABLE PHONE NUMBER AVAILABLE (cell)Research & Development Technology Transfer Lead Project Management Data Preparation and Presentation GMP and GLP Scientist In Vivo ScientistAccomplished professional with a diverse scientific background offering strong organizational, interpersonal, and time management skills. Strengths include excellent presentation and writing skills, following company principles, documentation maintenance and review, effective communication, coordination, mentoring/training, work independently or with a team to meet project timelines, and uphold company standards of quality.Project Coordination and managementData Analysis and InterpretationProgram Management for internal and external stakeholders.Proficient in Microsoft Suite, Prism, Electronic laboratory notebook, Mosaic, CyberLab, Watson, MSD, TrackWise, OneNote, TruVault, and standard lab-based software systems and instrumentationWriting Skills  Preclinical Research Study Protocols / Supporting Documentation; Technical Summaries; SOPs support and contribution, protocol support, review and editing supporting international documents and policiesDelegation and execution of function designs and tasks to supporting units.Professional ExperienceEurofins Lancaster Laboratories, Professional Scientific Services, LLCLancaster, PAClient services located in Malvern, PAposition changeTechnology Transfer LeadMaterial Sciences 2022-CurrentSupport the Material Science department on Life Cycle Management of raw materials for pharmaceutical manufacturing.Maintain raw material specifications.Material Science Technology Transfer supporting and maintaining material readiness for cGMP manufacturing of early or late phases development/commercial products.Candidate's Name  EMAIL AVAILABLE Page TwoSupport raw material qualification activities to meet health authority requirements.Ensure compliance with safety, GxP (GMP, GDP) quality and scientific principles.Experience includes but not limited to: Writing Specification documents, coordinating Material qualifications, working in a GMP and compliance environment.Participate in projects and scientific meetings to share information, knowledge, ideas, and judgment to help establish valid scientific directions in product development or investigations.Actively participate in cross-functional R&D and manufacturing teams to advance projects goals and deliverables related to raw materials.Proactively plan and multitask to maximize productivity.Meet all quality and productivity metrics and demonstrate strong teamwork and collaboration.System experience includes but is not limited to Microsoft Suite, TrueVault, Trackwise, and Sharepoint.Company Memberships: The Buzz newsletter, Events & Activity Committee (EAC), Eurofins Charity & Community Outreach (ECCO) Officer position: President.HireGenics Inc.Duluth, GA 2019-2021Client services for Janssen R&D Spring House, PAResearch Associate Scientist IIMicrobiome Department, Infectious Disease (IDR)Execution of general operational tasks associated with facilities, scheduling, assembly, preparation, coordination, delivery, and maintenance of study and program-related information.Conduct and document all experimental procedures and data in compliance with established protocols, plans, and approved electronic files.Report and submit data in an appropriate time frame.Focus primarily on phage display and bacterial growth assessments.Perform rodent dosing post preparation of material solutions.Process ex vivo tissue samples to determine colony forming units using laboratory instruments and methodologies.JANSSEN RESEARCH AND DEVELOPMENT, LLCSpring House, PA 2001  2017Positions held: Associate l Scientist, Associate ll Scientist, and Senior Associate ScientistDiscovery / Biologics ToxicologyPrepare and present independent and collaborative data at team and department meetings, internal scientific poster sessions, and external meetings, contributing to technical reports and various documents generated to support patent filings.Collaborate in a matrixed environment with cross-functional team members with open communication and transparency, effectively managing project team timelines and ensuring quality data presentation, management, and analyses of primary readouts in key studies.Candidate's Name  EMAIL AVAILABLE Page ThreeDesign, execute, and troubleshoot various research departments focused in vivo and in vitro experiments.Perform various rodent studies in biological research departments within discovery research, followed by independent data analysis and outlining path forward, maintaining accurate documentation in electronic notebook and experimental QC.Skilled multi-tasker, responsible for effective planning, execution, and prioritization of tasks supporting multiple discovery programs.Involved with Expert Connect in transitioning from laboratory tasks to a position utilizing personal and educational strengths in a manner supporting the company.Personal and developmental training programs including but not limited to Myers-Briggs evaluation, Birkman, StrengthsFinder, DiSC personality analyses in addition to both Franklin Covey and Skill Path courses.Coordinated multiple fundraising activities for community service events including Take Our Sons and Daughters to Work Day (chair 2015,2016), annual Backpack Drives for communities in need, and volunteer work with local hospitals in their pediatric events.EducationBachelor of Science (BS), Major: Industrial and Organizational Psychology, Cedar Crest College Allentown, PAConferred 2009Coursera: Specialization Certificate: Clinical Trial Operations.Course Certification Certificates: Foundations of Project Management, Clinical Trials Data Management and Quality Assurance, Clinical Trials Analysis, Monitoring, and Presentation, Drug Development, Design and Conduct of Clinical Trials, Clinical Trials Management and Advanced Operations, Drug Discovery.Professional Memberships and LicensuresNational Alliance on Mental Illness (NAMI), Lehigh Valley BranchAmerican Association of Laboratory Animal Sciences: Registered Lab Animal Technologist

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