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Click here or scroll down to respond to this candidateCandidate's Name
EMAIL AVAILABLEPHONE NUMBER AVAILABLEFrenchtown, NJ Street Address
SKILLSComputer literate in Microsoft Office, Provantis 10, Provantis Pathology, and Genetic Tox data capture systems as well as CARAPROFESSIONAL SUMMARYCurrently consulting for Biohaven Pharmaceuticals in the Nonclinical Optimization and Development group in Toxicology Operations. Served as a Supervisor/Manager/Coordinator at Charles River Labs and previously served as a Scientist in Discovery Toxicology at Bristol Myers Squibb, performing, and coordinating in vivo exploratory/investigative toxicology studies in large and small animals. Operating in a highly matrixed group for the advancement of early preclinical large and small molecule entities. A definite benefit to your organization, would be to apply over 30 years in the Pharmaceutical Industry serving in a variety of technical roles in preclinical GLP and non-GLP in vivo toxicology studies as well as serving in an administrative role as project coordinator/manager and study director on preclinical safety studies. Included in this vast experience is having worked in other therapeutic areas/biology groups and in the medical/surgical device arena. Deriving personal satisfaction from participating as a well-rounded team player who can forge cohesive, collaborative interactions as well as work in an independent setting in a fast-paced environment. Focal attributes are excelling at and seeing challenging projects to completion as well as learning and implementing new techniques in a timely fashion. Hopefully these qualifying attributes and experiences can potentially fulfill and excel in providing for the needs for this position and the organization by providing an invaluable resource derived from time spent in the large pharmaceutical/biotechnology industry. Many opportunities and new experiences would be provided by and envisioned through the advancement in an evolving skill set in this position within your organization.OBJECTIVE: Advancing a career as an integral part of a dynamic team involving Preclinical Toxicology, Pathology, Pharmacology, and/or other relevant Therapeutic areas.system for Regulatory submissions.Validation of laboratory equipment for GLP study conduct.Advanced training in necropsy/pathology/histolog ical preparation/evaluation of lab animals (rodents, dogs, non-human primates) and humans. Train and mentor junior associates and other Veterinary Science personnel in necropsy and pathology.Training in small and large animal surgery for device implantation and various vascular cannulations.All forms of dosing for small and large animal studies as well as rat infusion studies.Investigational Metabolomic/Transcriptional assays in rodents and NHP's for biomarker analysis for NMR and LC/MS.Use of telemetry system (DSI) for rodent infection studies. Perform large animal ECG's.Basic training in in vitro bacterial, mammalian cell mutation assays (i.e. AMES Assay, Mouse Lymphoma Assay) and in vivo micronucleus assays.Basic in vitro cell culture techniques and transcriptional studies. Basic training in Drug Safety Reproductive and Teratology studies.WORK HISTORYBiohaven Pharmaceuticals, Senior Consultant, Nonclinical Optimization and Development (remote)New Haven CT 03/2024 CurrentOperation management of Toxicology and DMPK studies/programs for discovery and development. Work with staff toxicologists and other safety scientists along with key resource CRO to ensure SOW and contracts are in place. Assist toxicologists in site audits as needed. Archival of data and study material. Work with Regulatory writing for IND, NDA, and IB submissions. Logistical operations of study placement at CROs and developing relationships nationally and international stakeholders.CHARLES RIVER LABS, Manager Necropsy-Horsham, PA 06/2022 - 02/2023Manage and supervise 10 techncal staffmembers and the workload assigned in GLP and non-GLP rodent and rabbit reproductive toxicology studies. Assist in the training and guidance of staff in necropsy and pathology of all small animal species relevant tocurrent toxicology models.Collaborate with other CRL sites worldwide in necropsy and histopathology issues.Review Provantis data from ongoing work and finalized data sets to be submitted for QAreview. Review and setup workload resources for necropsy team.Report to Operational management regarding financial needs and budgetary schedules.Collaborate and provide expertise for Study Directors, In- life teams and QualityAssurance regarding study performance and study issues.Bristol Myers Squibb - Principal Research Scientist IPrinceton, NJ 08/2004 12/06/2021Direct and supervise activities associated with in vivo discovery toxicology in small and large animals (including primates).Manage, employ, and monitor toxicology workflow of small and large molecules from research groups and advise in vivo technicians/associates of workload.Manage and maintain computer systems for main frame data capture (i.e., Provantis).Work closely with pharmacokinetic/metabolism group on study related activities and training.Provide technical expertise and training in gross pathology of small and large animals, small and large animal surgery.Provide technical in vivo assistance/support to molecular toxicologists and other therapeutic areas.Serve as Senior Study Coordinator/Study Director on non- GLP Discovery Toxicology for ECN submissions, Safety Pharmacology and Metabolomic/Transcriptional Studies as well as contract studies.Report all information to research groups as needed via physical reports or electronic media and present at team meetings and other national professional meetings.Work cross sites to collaborate on Discovery Toxicology/Drug Safety Evaluation/Biology studies in NJ, MA and CA.Served as a member of former Wallingford site IACUC committee.Helped to establish Discovery Toxicology in vivo resource and managed Wallingford in vivo group in Discovery Toxicology.Responsible for authoring/maintaining animal care and use protocols for IACUC submissions.Ethicon Products Worldwide/Johnson & Johnson -ScientistSomerville, NJ 04/2003 - 07/2004Corporate Product Characterization, Preclinical Safety Evaluation Main Responsibilities: Responsible for coordinating and participating in in-house and contracted in vivo/in vitro preclinical safety, efficacy, and biocompatibility studies with medical, surgical and drug coated devices.Develop and implement novel technologies that are applicable to Preclinical Safety Evaluation.Manage, coordinate and support GLP R&D activities to assess new and current products.Serve as project representative on national and international projects.Interact with internal and external customers during protocol generation, interfacing with IACUC, coordinating study, assembly and reporting of data.Assist in writing of biocompatibility risk assessments and generating final non-GLP, GLP Preclinical reports.Johnson & Johnson Pharmaceutical Research & Development, R. W. Johnson Pharmaceutical Research Institute - Senior Associate ScientistRaritan, NJ 12/1999 - 04/2003Conduct various tasks associated with design, conduct and reporting of drug discovery studies in in vivo bacterial assays generating accurate data and reporting in lab notebooks.PK/PD/TK determinations of new chemical entities.Apply basic scientific knowledge and understanding of in vitro toxicology theory for completion of assignments.Assist in design of studies and preparation of protocols.Identify study-related problems and potential solutions.Calculate, review and edit data.Maintain study files.R. W. Johnson Pharmaceutical Research Institute -Associate ScientistSpring House, PA 06/1994 - 12/1999Conduct various tasks associated with design, conduct and reporting of in vitro toxicity studies in bacterial and mammalian mutation assays generating accurate data in conformance with RWJ/PRI Research Practices and study protocols.Apply basic scientific knowledge and understanding of in vitro toxicology theory for completion of assignments.Also perform tasks during in vivo phases of reproductive/teratology studies necessary including dosing, weighing and observing animals, performing fetal necropsies, and Cesarean sectioning.Assist in design of studies and preparation of protocols.Identify study-related problems and potential solutions.Calculate, review and edit data.Maintain study files.Author and assemble reports.R. W. Johnson Pharmaceutical Research Institute -Research AssociateRaritan, NJ 09/1990 - 06/1994Conduct various tasks associated with design, conduct and reporting of toxicity studies in variety of animalspecies generating accurate data in conformance with RWJ/PRI Research Practices and study protocols.Apply basic scientific knowledge and understanding of toxicology theory for completion of assignments.Perform scientific tasks as necessary including dosing, weighing and observing animals, and performing necropsies.Assist in design of studies and preparation of protocols.Identify study-related problems and potential solutions.Calculate, review and edit data.Maintain study files.Draft and assemble reports.Assist in training of technicians.ACCOMPLISHMENTS2002 Recipient of Johnson & Johnson's Vice President's Research Award for Outstanding Technical Achievement in Support of Scientific Research & Development.PUBLICATIONS/ABSTRACTS/PRESENTATIONSRobertson, Donald, Stryker, Steven; Ruepp, Stefan; Aranibar, Nelly; Shipkova, Petia; Hnatyshyn, Serhiy; Foster, William. Combined Metabolomic/Transcriptomic Evaluation of the Effects of Overnight (16HR) Fasting on Sprague Dawley Rats. Applied and Investigative Metabonomics (Discovery Toxicology), Bristol-Myers Squibb Company, Princeton, NJ, USA.Sedor DD, Preston RF, Stryker SA, Oldham JW. An evaluation of 2-chlorodeoxyadenosine in a battery of genetic toxicity assays [abstract]. Environ Mol Mutagen 1998;31(Suppl 29):42.D. Abbanat, G. Ashley, J. Carney, M. Fardis, B. Foleno, J. Hilliard, Y. Li, P. Licari, M. Macielag, J. Melton, S. Stryker,E. Wira, K. Bush. In vitro and In vivo Activities of C-13- Propyl Ketolide Derivatives of Erythromycin A. The R.W. Johnson Pharmaceutical Res. Inst., Raritan, NJ; Kosan Biosciences (Abstract).J. J. Hilliard, S. A. Stryker, J. L. Melton, C. Bellinger- Kawahara, and K. Bush. Evaluation of antibacterial agentsusing real time in vivo bioluminescent imaging and conventional microbiological techniques. The R.W. Johnson Pharmaceutical Res. Inst., Raritan, NJ; Xenogen, Alameda, CA. (Abstract).D. Abbanat, G. Ashley, B. Foleno, H. Fu, J. Hilliard, Y. Li, P. Licari, M. Macielag, J. Melton, D. Raina, S. Stryker, D. E. Wira, K. Bush. In vitro and In vivo Antibacterial Activities of 15-methyl-2-fluoro Ketolides. Johnson & Johnson Pharmaceutical Research and Development, Raritan, NJ; Kosan Biosciences, Hayward, CA. (Abstract).D. Abbanat, G. Ashley, B. Foleno, H. Fu, J. Hilliard, Y. Li, P. Licari, M. Macielag, J. Melton, D. Montenegro, D. Raina, S. Stryker, E. Wira, K. Bush. 2003. In vitro and In vivo Antibacterial Activities of 15-methyl-2-fluoro Ketolides. Abstr. 1203. p 246. In Book of Abstracts, 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy. American Society for Microbiology; Washington, DC Monitoring Infection of Implanted Medical Devices with Bacteria Expressing Green Fluorescent Protein, James Comolli, Candidate's Name , Stephen Rothenburger, and Richard Hutchinson, Ethicon Inc., Somerville, NJ (R&D Science Day Poster presentation)J. J. Hilliard, J. Melton, S. Stryker, B. Foleno, T. Henninger, M. Macielag, K. Bush and D. Abbanat. .In vivo Antibacterial Activity of the C6-Carbamate Ketolide JNJ- 17069546. Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New JerseyS. D. Paget, R. M. Goldschmidt, J. J. Hilliard, J. Melton, S. Stryker, K. Bush, M. J. Macielag. In Vivo Antibacterial Activity of Pyrrolopyrazolyl-Substituted Oxazolidinones in a Murine Lethal Infection Model. Johnson & Johnson Pharmaceutical Res. & Dev., L.L.C., Raritan, NJ.The utility of stable isotope labeled (SIL) analogues in the bioanalysis of endogenous compounds by LC-MS applied to the study of bile acids in a metabolomics assay. Zheng JJ, Shields EE, Snow KJ, Nelson DM, Olah TV, Reily MD, Robertson DG, Shipkova PA, Stryker SA, Xin B, Drexler DM. Anal Biochem. 2016 Jun 15;503:71-8. doi:10.1016/j.ab.2016.03.011. Epub 2016 Mar 28.1H NMR-based lipidomics of rodent fur: species-specific lipid profiles and SCD1 inhibitor-related dermal toxicity. Khandelwal P, Stryker S, Chao H, Aranibar N, Lawrence RM, Madireddi M, Zhao W, Chen L, Reily MD.J Lipid Res. 2014 Jul;55(7):1366-74. doi: 10.1194/jlr.M049155. Epub 2014 Apr 22.Metabolomic and transcriptomic changes induced by overnight (16 h) fasting in male and female Sprague-Dawley rats.Robertson DG, Ruepp SU, Stryker SA, Hnatyshyn SY, Shipkova PA, Aranibar N, Mcnaney CA, Fiehn O, Reily MD. Chem Res Toxicol. 2011 Apr 18;24(4):481-7. doi: 10.1021/tx200074f. Epub 2011 Mar 25.Identification of 1- and 3-methylhistidine as biomarkers of skeletal muscle toxicity by nuclear magnetic resonance- based metabolic profiling.Aranibar N, Vassallo JD, Rathmacher J, Stryker S, Zhang Y, Dai J, Janovitz EB, Robertson D, Reily M, Lowe-Krentz L, Lehman-McKeeman L.Anal Biochem. 2011 Mar 1;410(1):84-91. doi:10.1016/j.ab.2010.11.023. Epub 2010 Nov 19.Modulation of ascorbic acid metabolism by cytochrome P450 induction revealed by metabonomics and transcriptional profiling.Aranibar N, Bhaskaran V, Ott KH, Vassallo J, Nelson D, Lecureux L, Gong L, Stryker S, Lehman-McKeeman L. Magn Reson Chem. 2009 Dec;47 Suppl 1:S12-9. doi: 10.1002/mrc.2503.Aranibar N, Bhaskaran V, Ott KH, Vassallo J, Nelson D, Lecureux L, Gong L, Stryker S, Lehman-McKeeman L. Magn Reson Chem. 2009 Dec;47 Suppl 1:S12-9. doi: 10.1002/mrc.2503.. |
