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Summary

holding a phd in Biomedical Engineering and a mba, Bio-industry management, cyril has a 15-yr background within the biotech, Medical Device, compliance and regulatory services, pharma/medical Supply Chain and wireless monitoring technology sectors. as a Co-founder of biosyntech canada inc. in 1997, he worked as senior Scientist for the development of the injectable temperature-gelling biomaterial platform, then he designed and developed the derived injectable bone substitute platform as bone substitutes development, manager. cyril also acted as manager of technology & Intellectual Property. in 2002, cyril joined angiogene inc., an endovascular device company, to hold the positions of Director of Business Development & Intellectual Property and Project Leader for radio-labelled endovascular devices. cyril joined pharma-concept inc./validapro inc. to launch a contract biomanufacturing project (laborium biopharma) and to work on strategic plans for specialized biomanufacturing, specialized Pharmaceutical services, and targeting of future generic injectable and cytotoxic drugs. from 2005 to 2012, he worked as Regulatory Compliance specialist and manager of Marketing & export for alternatives technologie pharma, a cold chain services company. specialized in oq/pq on cold chain Packaging methods. in 2010-2011, he joined oligo medic inc., a Medical Device company (biopolymer), and is now acting as vp Regulatory Affairs & quality manager at oligo medic inc. since 2012, cyril is working as cold chain and gdp specialist, and vp Regulatory Affairs at infitrak inc., a cold chain regulatory/technical services and monitoring solutions provider for the.Life Sciences markets. cyril chaput is iso9001:9008 (tpecs) lead Auditor certified. specialties: cold chain, gdps, Supply Chain, Medical Devices, iso13485, compliance, regulatory, qa/qc, Business Analysis, strategic Marketing, Intellectual Property, project/Product Development, biotech, monitoring,

Experiences

Current Experience

  • Vice-president, Quality Assurance & Regulatory Affairs


    Since January 2011
    manager qa infitrak and iso9001:2008 certification. cold chain solutions and services, regulatory and technical services (qms), regulatory Engineering services, Packaging services, monitoring services and solutions (ems), gdps for life science, Healthcare, Logistics and agri-Food. custom Software & system development for Life Sciences Manager QA Infitrak and ISO9001:2008 certification. Cold Chain Solutions and Services, Regulatory and Technical services (QMS), Regulatory Engineering Services, Packaging services, Monitoring Services and Solutions (EMS), GDPs for Life Science, Healthcare, Logistics and Agri-food. Custom Software & System Development for Life Sciences

Past Experience

  • VP Regulatory Affairs & QA Manager

    January 2011 --- January 2015
    injectable class iii-iv thermoforming devices for repair Applications; Medical Devices, injectable devices, biopolymers, musculo-skeletal, Product Development manager for iso13485 certification and ce mark

  • Cold Supply Chain Compliance Specialist, Director of Marketing

    July 2005 --- March 2010
    developer and provider of services and solutions for pharma/biotech/medical companies, cros, cmos, wholesalers, 3pls provider, transporters, laboratories, Hospitals and pharmacies: -cold chain Compliance and technical services: regulatory gap Analysis, Training, regulatory Documentation support, Qualification and Validation, stability studies program... -cold chain monitoring and tracking solutions: environmental conditions monitoring and tracking for storage and distribution, data loggers and thermoucouples, global cold Supply Chain tracking solutions... -cold chain Packaging solutions: design and test of cold chain Packaging methods, Qualification (oq/pq) of Packaging methods/processes, insulated reusable coolers, packages and shipping supplies...

  • Scientific Advisor

    January 2003 --- January 2005
    orientation and elaboration of a contract biomanufacturing strategic plan. design and development of a strategic alliance with a public institution (cnrc). development of strategic plans for specialized biomanufacturing, specialized Pharmaceutical services, and targeting of future generic injectable and cytotoxic drugs. coordination of Compliance levelling up of cGMP Clinical biomanufacturing installations

  • Director, Business Devlt & IP / Project leader

    January 2001 --- January 2003
    development of Intellectual Property pipeline, ip Licensing opportunities and infringement risks, technological survey and Analysis of technological environments. evaluation & Analysis of corporate and technological projects for Licensing or merge & acquisition. development of Documentation packages for business partnerships. evaluation & re-orientation of development programs for endovascular devices and regulatory position in regard to iso13485 standard, management of contract developed Product Development and prototyping contracts. identifiction and audit of Clinical Manufacturing and distributing sites for radio-labelled endovascular devices.

  • Director, IP

    January 1996 --- January 2001
    initiated and managed Intellectual Property protection activities for patent Applications and trademarks.

  • Director, Bone Products Development

    January 1996 --- January 2001
    development of a R&D team for a novel generation of injectable composite bone substitutes, directed on injectable bone products development program. design and development of bst-ossifil and bst-ossifix bone products.

  • Senior Scientist

    January 1996 --- January 2001
    development of the company’s technological strategic plan and ip pipeline. developed injectable biomaterial platform. chemical and toxicological studies.

Personality

Self Assessment :
Analytical thinkingCritical thinkingInterest in knowledgeService oriented

Knowledge

Self Assessment :
Medical devicesCAPAValidationPreclinical regulations and practicesMarket accessGood Manufacturing Practice (GMP)Microsoft OfficeQuality Assurance (QA)Writing Study Procedures and SOPsRegulatory affairsRegulatory RequirementsPilot scale batchesQualificationOrthopedicRegulatory StrategiesRegistration of the productPharmaceutical Industry
LinkedIn Assessment :
Medical DevicesBiotechnologyComplianceIntellectual PropertySupply ChainLife SciencesLifesciencesQuality SystemsValidationGMPISO 13485Quality Assurance (QA)BiopharmaceuticalsProduct developmentFDAPharmaceutical IndustryRegulatory affairsPharmaceutics

Skills and Expertise

Self Assessment :
Develop protocolsWritten presentation Design case record forms Create SOPsDesign efficiency studyDesign protocol

Education

  • MBA in Bio-industries Management from Université du Québec in 2003
  • PhD in Biomedical Eng from Université de Montréal - Ecole polytechnique de Montréal in 1995
  • M.Sc. in Exp. Medicine from Université Laval in 1992

Training and Certification

  • ISO9001:2008 auditor in 2014 Certification

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Professional Proficiency

Work Preferences

  • Notice Period:
    2 weeks
  • Positions I am interested in:
    Quality manager Regulatory Affairs Manager
  • Locations I am interested in:
    Montréal, QC, Canada
  • Work From Home:
    Yes, 0 to 2 days per week
  • Work Regime:
    BrightOwl freelancer :    20 Hours per week
  • International:
    Yes

Area / Region

Montréal, QC, Canada

Others

Driving License
  • No

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