Leah Markowitz Lake
Group Leader of Autoradiography at XenoBiotic Laboratories, Inc., a wholly owned subsidiary of WuXi AppTec, Inc.- Claim this Profile
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Bio
Credentials
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Phoenix WinNonlin
PharsightMar, 2013- Nov, 2024 -
DOT Training for Life Sciences
Safety Partners,Inc.Oct, 2013- Nov, 2024
Experience
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WuXi AppTec, Laboratory Testing Division, New Jersey site
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Group Leader of Autoradiography
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Aug 2015 - Present
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Invicro
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United States
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Biotechnology Research
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300 - 400 Employee
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Manager of Autoradiography
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Jun 2013 - Jul 2015
Responsible for the design, planning, build-out, and development of the Autoradiography laboratory within the newly constructed laboratory space; plan and establish the budget for the group; help monitor and manage the budget. Responsible for the planning and execution of multiple on-going studies. This includes protocol preparation and initiation, procedural documentation and continued supervision for all phases of the project, and report writing and generation. Coordinate cross-functionally with Radiochemistry, in vivo, and Image Analysis groups to maintain study schedule, calculate dose formulations, plan resources, and maintain budget to achieve study-specific goals within specified timelines. Responsible for leading a group of technical staff, including mentoring and training in all laboratory techniques, organization and function of the laboratory. Responsible for the validation, operation, and maintenance of instruments including the Leica 3600 cryomacrotome, Leica 3050 cryomicrotome, and Fujifilm BAS 5000, FLA 5100, and FLA 9000 scanners Developed and established a company-wide SOP, notebook, and logbook system; including creating forms and templates, implementing a numbering scheme and tracking procedures; responsible for issuing all new requests. Key individual in overseeing the procurement of all laboratory purchases; responsible for purchasing and tracking all incoming laboratory purchases; help establish an inventory and tracking system for all laboratory equipment, instrumentation and supplies, including obtaining quotes and providing POs; aided in creating a tracking system for all quotes, POs, and invoices. Member of the IACUC, SOP, and Safety Committees. Authorized user on the radioactive material license; trained and certified in Department of Transportation (DOT) for Life Sciences; authorized to ship , receive, and inventory chemicals, test articles, and study-related samples. Show less
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WuXi AppTec, Laboratory Testing Division, New Jersey site
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Study Director
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Mar 2011 - May 2013
Responsible for the planning and execution of multiple on-going studies. This includes protocol preparation and initiation, procedural documentation, and continued supervision for all phases of the project, and report writing and generation.Establish and maintain relationships with clients, and execute projects within both GLP and Non-GLP regulations according to FDA guidelines and standard operating procedures.Implement projects according to pre-defined client specifications - specifically tissue distribution, pharmacokinetic, and mass balance studiesCoordinate cross-functionally with Bioresources, Analytical Services, and Biotransformation groups to maintain study schedule, calculate dose formulations, plan resources, and maintain budget to achieve study-specific goals within specified timelines.Present and market to prospective clients the advantages of Xenobiotic Laboratories’ technology and practices during site visits.Accountable for assisting in leading the training, documentation, and validation of Phoenix® platform for Pharsight WinNonlin 6.3. Show less
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Team Leader/Staff Scientist
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Feb 2009 - May 2013
Responsible for leading a group of three technical staff, including mentoring and training in all laboratory techniques, organization and function of the laboratory.Co-developed the Autoradiography laboratory; responsibilities included generating and implementing new documentation, validating new instrumentation, procedures, and software, authored all department SOPs and STPs.Integral part of the team for developing breakthrough 3D modeling technology, allowing for generating the highest known resolution and the most accurate tissue analysis in the field.Responsible for the operation and maintenance of instruments including Leica 9800 cryomicrotomes, Fujifilm BAS 5000 Image Scanner, and the Fujifilm BAS 1800II Image Scanner.Set up and execute tissue distribution studies for pharmacology, toxicology, and dosimetry following SOPs and GLP regulations.Actively involved in the hiring process of new department employees. Show less
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Associate Scientist
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Jul 2007 - Feb 2009
Conducted in vivo and in vitro drug metabolism studies for pharmacology and toxicology, identifying metabolite profiles accrued from HPLC and LC/MS methods, following SOPs and GLP regulations.Performed analytical assays, beginning with sample preparation, extraction and chromatography, and reporting the findings in data summary reports and final reports.Set up, operate, and maintain instruments including Waters and Shimadzu models HPLC; Sciex API 4000 series mass spectrometers, FujiFilm Bas 1800II Image Scanner.Laboratory supervisor of the HPLC laboratory area as well as responsible for TLC chromatography.Train and assist new employees on techniques used in the laboratory to successfully conduct studies. Show less
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Education
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Kean University
Bachelor's of Science (B.Sc.), Chemistry, Physics -
Kean University
Master of Science (M.Sc.), Biotechnology