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Summary

Executive Summary

Founder of Biopremier S.A., a diagnostics company, having played important roles in business development and strategy, raising Venture Capital, funding for R&D projects, and defined research focus areas.

Developed CE IVD and Accredited molecular biology tests, from Design of molecules, through Optimization, Performance studies and IP processes.

Design and setting-up of Testing laboratories and an IVD Manufacturing Unit.

Implementation of two Quality Management Systems (ISO 17025 and 13485).

 

Main Achievements

Founder of Biopremier S.A., a biotech company, with ca. 30 employees.

Developed human diagnostic tests focused on infectious diseases and genetics (CE IVD marked/Accredited). Design of performance studies, collaborations with Hospitals and ethics committees.

Developed IVD tests for Animal Health (infectious diseases) and Food sector (food authenticity).

Coordinator of a team responsible for the creation of a software program for the design and evaluation of DNA/RNA molecules, and construction of DNA sequencing libraries.

Implementation of the Certification as IVD MD Manufacturer (ISO 13485 – GB14/92435, SGS UK).

Implementation of a flexible scope, type B Accreditation (ISO Standard 17025 - L0507; IPAC).

Author of scientific papers and Patents.

 

Projects and Awards

Trophy Desafio for innovative companies, on behalf of Biopremier, presented by the Magazine Invest, 2011, Portugal.

Project QREN SI I&DT HemoPAB nº30242 (2013-2015) – Development of a test for hemo-parasites and bacterial anaemias – Coordinator

Project QREN SI I&DT Co-Promotion (Leader of the Consortium) RTI-CD nº1597 (2008-2012) – Development of a new test for Lower Respiratory Infections - Coordinator

Project Prime SIPIE (2007-2008) nº00/24162 – Construction and Accreditation of Testing Laboratories - Coordinator

Finalist of the Award Prémio Milénio Sagres-Expresso 1999 – Study of Atlantic populations of Sardina pilchardus - Author

Experiences

Current Experience

  • Board Member, Head of the Clinical/Animal Health Diagnostics Unit, Technical Director/QM of Production Unit (ISO 13485) Lisbon, Portugal
    Since September 2003

    - Founder of Biopremier and Board Member, having completed several rounds of funding and participated in an IPO – 2003 until present.

    - Strategic thinking and business development. Networking with KOL and presentation of technical and commercial information – 2003 until present.

    - Coordinator of the development of a wide portfolio of molecular biology tests for Human diagnostics, Animal Health and Food quality – 2003 until present.

    - Quality Manager and responsible for the implementation of a type B (in-house development), flexible scope Accreditation according to ISO 17025; the first obtained in Portugal – 2009-2011.

    - Coordinator of the implementation of the Certification according to ISO 13485, for IVD products, assuming the role of Technical Director since 2012, and Quality Manager since 2014.

Past Experience

  • Molecular Biologist Lisbon, Portugal
    September 2005 --- September 2006

    Diagnostics work, performing paternity tests in Dogs and Horses and optimizing new tests.

  • Scientific Researcher Caparica, Portugal
    September 2000 --- August 2003

    Research work on the phytopathogenic fungi Taphrina, studying its taxonomy, genetic diversity, and
    co-evolution with its hosts.

  • Scientific Researcher Lisbon, Portugal
    September 1997 --- August 2000

    Research work on the crustacean Artemia, regarding its genetic, morphological and ecological characteristics in Portugal. Work on intensive and semi-intensive production of Artemia and its biochemical value, for fishes produced in aquaculture.

Personality

Self Assessment :
Strategic thinkingProblem solvingInnovative thinkingEfficiencyCoordinationAttention to detailOptimismResponsibilityProactivityAdaptability

Knowledge

Self Assessment :
Business StrategyCE CertificationGeneticsGXPIn vitro diagnostics (IVD)Infectious diseasesISO 13485ISO 17025Laboratory ManagementLeadershipmolecular biologyProblem SolvingQuality Assurance (QA)Regulatory affairsRisk AssessmentSequence AnalysisStart-upsStrategic Financial Planning
LinkedIn Assessment :
LifesciencesDNAmolecular biologyBiotechnologyLaboratoryPCRGenomicsMicrobiologyIn vitro DiagnosticsResearch ProjectsISO 13485 IVD ManufacturersISO 17025 AccreditationVenture CapitalBusiness DevelopmentR&DLife Sciences

Skills and Expertise

Self Assessment :
Molecular DiagnosticsWriting regulatory documentsAdvise on strategyBiomarker ResearchCollaborate with medical teamDevelop Quality Risk Management (QRM) initiativesEvaluate stability data Execute scientific projectsImplement Quality Management System (QMS)Interact with KOLLead teamsManage laboratory proceduresExperience in IVD sector - DesignDevelopmentValidation and CertificationR&DValidation and Certification of IVD tests

Education

  • 4-year Degree in Biology, 1996 in Biology from University of Aveiro in 1996

Training and Certification

  • Clinical Investigator Certification, Level 1, according to Pharmatrain syllabus. UNAVE (Univ. of Aveiro) and PtCRIN (NOVA Medical School, New Univ. of Lisbon). in 2016 Certification
  • Advanced Programme of Management and Innovation for Entrepreneurs (BES PAGEmpreendedores), Católica Lisbon (School of Business & Economics) and University BES. in 2013 Certification
  • Audits to Testing Laboratories, according to ISO Standard 17025:2005, Specanalitica in 2009 Certification
  • IV Theoretical and Practical Course on Molecular Microbial Taxonomy, 5th-10th February 2001, University of Lisbon in 2001 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Portuguese
Native
English
Full Proficiency

Work Preferences

  • Notice Period:
    3 weeks
  • Positions I am interested in:
    Development Manager Laboratory Manager Molecular Biologist Production Manager QA Consultant R&D manager Regulatory and Start-Up Specialist Scientific Advisor Business Development Manager Clinical Development Consultant
  • Work From Home:
    Yes, 1 to 5 days per week
  • Work Regime:
    Permanent position :    50-100% FTE
    BrightOwl freelancer :    20-50% Free Per Month(in coming months)
  • International:
    Yes

Publications

    Expert has 8 publications (Will be avalible with full profile)

Area / Region

Lisbon, Portugal

Others

Driving License
  • Yes