Scientific consultant León, Spain
Since October 2017
•Consult and advice in all technical, scientific and business aspects of Drug Discovery Services.•Facilitate leads (potential clients) to enhance the company business and also enhance the foot hold of the company in the pharma industry especially in Japan. •Strategic planning and business integration to capture the CRO market.•Selection, development and on-going improvements of the synthetic routes for intermediates and API.•Provide solutions for complex chemistry.•Assist the company to identify drugs which the company can work on to initiate technology transfer to CMO.Supervise the CRA work team. Ensure compliance with SOP and ICH/FDA regulations, providing written reports.
Senior Clinical Research Associate (CRA) León, Spain
Since April 2017
•Supervise the CRA work team. Ensure compliance with SOP and ICH/FDA regulations, providing written reports. •Carry-out independent qualification, initiation, monitoring and closure visits to centres and prepare correspondence and associated documentation. •Plan, coordinate, implement and manage clinical monitoring as indicated by the project team and project deadlines. Communicate with sponsors, sites, and colleagues to ensure effective project management.
Since January 2012
DEPARTMENT OF APPLIED CHEMISTRY LABORATORY FOR HYBRID RESEARCH •I develop the synthesis of inorganic/organic hybrid materials based on aromatic phosphonic acid derivatives. •I am supervising two master students and their research in the synthesis of the organic materials, including phosphonic acids derivatives and sulphone compounds that then will be coupled or grafted into the inorganic moiety. •I take part in ALCA, a multidisciplinary and multi centre project to develop the next generation of Li batteries where I develop PEO based solid polymer electrolytes. •02/2014: I took part in a 3 week scientific exchange with the Institute Charles Gerhardt, Montpellier to develop the synthesis of PEG allylated derivatives and its corresponding silylated product.
Lecturer at ICSEP
April 2013 --- March 2017
•Lecturer at Waseda University's International Center for Science and Engineering Programs (ICSEP) of the Introduction to Industrial Chemistry Course, Introduction to Applied Chemistry Course, Industrial Chemistry Course and Analytical Chemistry Course
September 2010 --- July 2011
•Develop new synthesis and purification methods for the synthesis of novel metal nanoparticles and further nanoparticle surface functionalization with polysaccharide derivatives that will be used as drug delivery systems. •Characterization of the nanoparticles using classical physicochemical methodology and also spectroscopic techniques such as TEM and AFM. •Collaborate at all company levels in the definition of initial administrative steps and regulatory requirements needed to start clinical trials using the innovative company products.
Clinical Investigation Assistant (CIA)
June 2008 --- September 2010
•Site selection, initiation, monitoring and close-out in accordance with ICH GCP and company SOPs. Ensure that investigational product is handled locally according to ICH GCP, SOPs and local regulations. •Troubleshoot and resolve site related issues and communicate protocol deviations, data quality problems and site performance issues to the lead CRA/Project Manager. Assist the lead and project manager with any other study specific duties. •Write and circulate monitoring reports and follow-up letters within the project specific deadlines. Maintain files of site records to be reconciled against site files during monitoring visits and against project files.
Clinical Research Associate (CRA)
September 2006 --- April 2008
•Provide site management and project coordination between sponsors, sites and colleagues to ensure effectiveness and adherence to protocol in Phase III clinical trials and Medical Devices studies. Interact at multiple levels within client organization including source data verification and implementation of corrective or new actions. Flexible attitude with respect to work assignment, new learning and travel. •Conduct initiation, interim monitoring and close-out visits in compliance with GCP and ICH/FDA regulations and preparing the corresponding visit reports in a timely manner. Presentation of the new projects and amendments to the ECs and CA in compliance with local regulations. •Projects: Multiple Sclerosis, Ulcerative Colitis Device, Acute Ischemic Stroke, Psoriasis, Follicular Lymphoma, Cervical Cancer (in vitro medical device) and liver cell transplantation.
September 2004 --- November 2005
•Developed, validated and implemented HPLC, UPLC, UV and FTIR methods for the quality control analysis of generic hormonal products impacting all sales to the US market. •Responsible for sharing best practices and infusing learnings across the entire organization including other countries. •Managed a team of three people and directed five projects running concurrently, with special ability to prioritize workload, define steps needed to achieve specific projects outcomes and deadlines and with great attention to detail
October 2002 --- July 2004
•Developed and maintained a constant supply of stock products such as neurochemicals, biochemicals, peptides, radioligands, pharmacological probes or signal transduction agents for sale to third parties. We developed more complex molecules relative to our competitors and followed very strict in-house quality regulations that were of a higher level than the standard manufacturing guidelines. •Discovered innovative methods for synthesizing and developing new catalogue products to add to the existing offerings by combining traditional methods with cutting edge technologies. •Designed and manufactured customized products for key clients such as pharmaceutical companies and research institutes around the world. Proven ability to reduce the synthetic steps in the routes for key products and increase the yields to customer satisfaction
Anger commandImpulse commandSelf-confidenceReaction to stressAssertivenessPerspectiveCuriosityAuthenticityCharmDependability
AdaptabilityAnalytical thinkingAttention to detailCollaborationCommunicativeCoordinationCreative thinkingCuriosityEfficiencyFlexibilityInnovative thinkingInterest in knowledgeProactivityProblem solvingResponsibilitySelf-disciplineSociabilityStrategic thinkingWillingness to compromiseService oriented
Skills and Expertise
Analytical skills Write papersAttend seminarsAttend investigator meetingCollect dataCollect patient forms and questionnairesCommunicate with investigatorCommunicate with sponsorCommunicate effectively on different company levelsConduct literature searches.Conduct research at universitiesConduct site initiationConduct the trialConduct university research Design scientific experimentsEthics committee applicationEthics committee submissionsEvaluate impurity synthesisEvaluate physico-chemical dataExecute scientific projectsGuide studentsInitiate clinical trials Interact with ethics committeeInteract with nursesInteract with pharmacistsInteract with physiciansInterpret scientific dataManage multiple projectsManuscript preparationManuscript preparation and reviewOperate research equipmentOrganise meetingsPrepare manuscriptPrepare regulatory documentsPresent data at congressR&DRegulatory documentationRegulatory submissionsReport non-compliance incidentsReport serious adverse events (SAE)Research at universitiesResolves queriesReview queriesSchedule trial visitsScheduling trial visitsSetup of research equipmentSubmit regulatory applicationsStudy-related documentsSupervise techniciansTeach university studentsTeachingUnderstand protocolsWork collaboratively with the other members of the clinical research team Work cross-functionallyWork under specific instructionsWrite documentsWrite papersWritten presentation
Master in Nanoscience and Nanotechnology from Universitat de Barcelona in 2011
Ph.D Chemistry in Organic Chemistry from University of Bristol in 2003
BS and MSc in Chemistry from Universidad de Salamanca in 1997
in from 早稲田大学 in 0
Training and Certification
Useful statistical knowledge in research in 2010 Training
Basic Knowledge of Radiochemistry, Safe Handling Techniques and Protocols Course in 2003 Training
Understanding LC-MS. Interpretation of LC-MS Data Course in 2003 Training
Expert has 3 publications (Will be avalible with full profile)