L. Kathleen Maley, MBA, MS, PMP

Experience

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  Army Corps Of Engineers

  Jan 1993 - Jan 1998

  Microbiologist

  Implemented EPA regulations regarding biological quality of drinking water. Evaluated comparison studies of analysis methods, and environmental trends effecting treatment process. Implement improved quality control procedures, and sampling plan for the District of Columbia. Investigated contamination sources and recommend improved sampling technique and systems operations. Improved reporting methods within the organization and to outside agencies. Served as Lead MicrobiologistAwarded Department of the Army Outstanding Performance Award, and Department of the Army Suggestion Award for contributions. Show less

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  GSK

  Jan 1998 - Jan 2004

  Scientist

  Utilize 10L-34 bioreactors for production of recombinant proteins in mammalian, insect, hybridoma, E. coli expression systems. Perform large scale adenovirus production. Write and maintain Best Practice Procedure Documentation for satellite groups worldwide. Manage laboratory workload and queue. Develop web-based database Responsible for databases, inventory records, and distribution of biological archive. Independently grow and cryopreserve various plasmid, bacteria, yeast, virus, insect cell lines and mammalian cell lines for research and development efforts. Grow, evaluate, and phage stocks for phage transductions. GMP compliance efforts- GMP trained, responsible for the preparation of GMP documentation, training of others on SOP's, and support and preparation and distribution of GMP banking activitiesAwarded Multiple Awards for contributions made. Show less

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  GSK

  Jun 2004 - Jan 2007

  Molecular Biologist

  Design constructs and expresses proteins for screening and use in crystallography studies. Evaluate techniques to enrich for high expressers in E. coli, viral and mammalian systems. Independently plan and execute experiments as needed for individual projects. Work closely with project teams. Organize, interpret, and present experimental findings. Leadership / Project Management Contributions at GSK• Developed company's first web-based biological archive. o Determined international cross-functional best practices of newly merged company, worked closely with IT development team and provided troubleshooting through test and into production. o Facilitated end-user education and compliance, increasing participation from <30% to >85% of validated materials.• Organized efforts to harmonize and horizontally integrate best practices across disciplines at bench scientist level. Awarded multiple Bronze (achievement) awards for contributions made. Show less

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  Merck

  Jan 2009 - Aug 2012

  Assay Development and Screening for multiple targets on various platforms including FLIPR, cAMP, ligand uptake, and membrane binding assays. Examine effects of siRNA on primary neuronal cell culture via High Content Imaging. Investigate cell toxicity panel for siRNA DRG injection studies. Identify and evaluate biomarkers of weight gain associated with atypical antipsychotic treatments, and markers to identify pathways of target MOA. Participate in safety committee and lab planning efforts. Received Special Achievement Award. Leadership / Project Management Contributions at Merck• Spearheaded Process Excellence Initiatives and cost effectively increased automation, assay efficiencies, and safety. o Received multiple Special Achievement Awards, highlighting efforts in collaboration and increased productivity.O Trained in Six-Sigma Yellow Belt and 5-S Initiatives to address ongoing safety and space resource concerns.• Selected as Philanthropic Representative, relaying impromptu patient feedback and volunteering in lieu of fiscal support.• Led on-site implementation of IT-based virtual archive of biological reagents and developed compound analysis tools. Show less

  • Program Team Scientist, InVitro Pharmacology

    Jan 2009 - Aug 2012

  • Biologist

    Feb 2007 - Apr 2010

  • Program Team Biologist; Pyschiatry

    Jan 2009 - Jan 2010
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  Percepticore, LLC

  Aug 2012 - Jun 2013

  QA Regulatory Consultant

  Providing Regulatory Compliance Solutions to the Biopharmaceutical Industry

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  Teva Pharmaceuticals

  Nov 2013 - Aug 2015

  Research Scientist

  Developed and validated assays for novel targets of Neurodegenerative Diseases, including ALS and Huntington’s Disease

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  Sanofi

  Aug 2015 - May 2016

  Project Manager, Continuous Improvement; Sample Coordinator, Manufacturing Technology

  Project management of continuous improvement initiatives to decrease deviations and increase productivity Project coordination of approval and sampling requirements, delivery and results for Redesign of Influenza Production. Coordinating accurate SAP, LIMS, and LabWare requests and reporting

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  Merck

  May 2016 - now

  Scientific Leadership & Research Manager

  • Project manager for Investigator Initiated Studies program including focus on Oncology, Immunology, HIV, and Women’s Health programs to ensure review, regulatory documentation, drug supply, and milestone payments are executed in accordance with tight deadlines and compliance requirements. • Responsibilities include management of over 89 simultaneous clinical and pre-clinical studies and complete budget totals in excess of $40 million.• Manage and coordinate execution of executive engagements with external experts to pressure test and inform strategy, resulting in key actionable recommendations by driving logistic, budget, legal and content concerns and development in compliance with global and local laws and internal processes.• Subject Matter Expert -Asia Pacific Region, in Scientific Leader Engagement, study related regulatory issues, and cross functional process Show less