Bernard Sagaert

Bernard Sagaert Email and Phone Number

CEO at etherna - Senior Consultant and CEO at Inphacon bv - Board member @ etherna
Bernard Sagaert's Location
St-Katelijne-Waver, Flemish Region, Belgium, Belgium
Bernard Sagaert's Contact Details

Bernard Sagaert work email

Bernard Sagaert personal email

About Bernard Sagaert

I am a CEO at etherna, a biotech company that develops mRNA-based platforms to enable partners to develop therapies. I have over 25 years of experience in the life sciences industry, with expertise in advanced therapy medicinal products (ATMP), manufacturing process improvement, regulatory affairs, and quality assurance. I am also a board member at flanders.bio, the leading life sciences cluster in Flanders.As a leader and entrepreneur, I combine operational management with strategic thinking, focusing on company growth, innovation, and excellence. I have a proven track record of coaching and mentoring teams, building strategic partnerships, navigating complex regulatory environments, and solving problems in a fast-paced and dynamic sector. I am passionate about creating value for patients, stakeholders, and society through the development and commercialization of cutting-edge biotech solutions.Besides work, I am a contemporary art enthusiast.

Bernard Sagaert's Current Company Details
etherna

Etherna

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CEO at etherna - Senior Consultant and CEO at Inphacon bv - Board member
Bernard Sagaert Work Experience Details
  • Etherna
    Chief Executive Officer
    Etherna Oct 2023 - Present
    Niel, Be
  • Etherna
    Interim Ceo
    Etherna Aug 2022 - Oct 2023
    Niel, Be
  • Etherna
    Chief Operational Officer
    Etherna Apr 2021 - Oct 2023
    Niel, Be
  • Etherna
    Svp Manufacturing
    Etherna Apr 2021 - Feb 2023
    Niel, Be
  • Etherna
    Vp Manufacturing
    Etherna Dec 2018 - Apr 2021
    Niel, Be
    Responsible for mRNA production, QC, QA and process development
  • Etherna
    Qa/Qc Lead
    Etherna Sep 2018 - Nov 2018
    Niel, Be
  • Etherna
    Qa Lead
    Etherna Dec 2017 - Aug 2018
    Niel, Be
  • Etherna
    Gmp Consultant
    Etherna Jun 2017 - Dec 2017
    Niel, Be
  • Alliance For Mrna Medicines
    Member Board Of Directors
    Alliance For Mrna Medicines Oct 2023 - Present
  • Inphacon
    Senior Consultant Life Sciences - Managing Director
    Inphacon Dec 2012 - Present
    International consultancy and services to the life science industry- QPo Qualified persono Batch releaseo Establish Quality agreementso Application for official licenses (manufacturing/distribution/batch release/export/...)o Trainingo Guidance on QM implementation in ERP (SAP)- Interim QA Management- Audito GMP/ISO supplier and internal auditso GDP Audits o Inspection Preparation, Training and Management- Quality systemso Quality Management and Systems: set up and maintenanceo SOP/Work instruction/form development and writingo Advice and assistance in setting up a Quality Assurance functiono Advice on compliance issues - GDP and GMP o Product classification advice- Medical informationo Medical information complianceo Responsible for medical information- Multi-functional project lead - Specialtieso Genericso Sterilization (EO/Gamma/Ebeam)
  • H.Essers
    Qualified Person
    H.Essers Jan 2017 - Aug 2024
    Genk, Be
  • Flanders.Bio
    Board Member
    Flanders.Bio Apr 2023 - Jul 2024
    Ghent, Flemish Region, Be
  • Sterigenics
    Vice President Ra/Qa Emeaa
    Sterigenics Oct 2010 - Dec 2012
    Oak Brook, Il, Us
    - QA/RA Support, guidance and control 10 European and Asian Sites- Crisis/Issue management- Governmental affairs- Customer contactsMember of EMEAA management committee
  • Mylan Bvba - Docpharma Bvba
    Qa & Supply Chain Director Belgium
    Mylan Bvba - Docpharma Bvba Jan 2010 - Oct 2010
    Canonsburg, Pennsylvania, Us
    Responsible for all Quality and Supply Chain activities in BelgiumQualified personResponsible for medical informationMember of the Executive CommitteeMember of the Management Committee
  • Docpharma
    Technical Operations Director
    Docpharma Sep 2007 - Jan 2010
    Be
    Resp. for Quality AssuranceResp. for Supply ChainResp. for PharmacovigilanceResp. for DistributionResp. for ITMember of Management teamMember of Direction Committee
  • Docpharma
    Qualified Pharmacist
    Docpharma Apr 2005 - Jan 2010
    Be
  • Docpharma
    Qualified Person For Pharmacovigilance
    Docpharma Apr 2005 - Jan 2010
    Be
  • Docpharma
    Responsible For Pharmaceutical Information
    Docpharma Apr 2005 - Jan 2010
    Be
  • Docpharma
    Qa & Ra Director
    Docpharma Apr 2005 - Sep 2007
    Be
    Responsible for Group quality procedures.Responsible for Group PharmacovigilanceResponsible for BeLux Regulatory procedures.Part of the Management team
  • Purna Pharmaceuticals
    Ict Manager
    Purna Pharmaceuticals Sep 1999 - Mar 2005
    Responsible for maintaining and improving the ICT infrastructure and software of a pharmaceutical company.Implementation of SAP.
  • Purna Pharmaceuticals
    Ra Manager
    Purna Pharmaceuticals Feb 1998 - Mar 2005
    Responsible for getting new marketing authorisations, update and maintain others, worldwide.
  • Farmabel
    Ra Manager
    Farmabel Nov 1993 - Feb 1998
    From product manager to Ra Manager, incl Responsible pharmacist

Bernard Sagaert Skills

Regulatory Affairs Gmp Pharmaceutical Industry Quality Assurance Quality System Medical Devices Pharmaceutics Quality Management Capa Validation Fda Iso 13485 Sop Change Control Continuous Improvement Biotechnology Change Management Technology Transfer Regulatory Requirements Pharmaceuticals Iso Lifesciences V&v Regulatory Submissions Glp Gcp Cro Bpf Quality Auditing Sap Sterilization Six Sigma Biopharmaceuticals Cleaning Validation Gxp Medical Affairs Generic Programming Computer System Validation Clinical Trials Quality Control 21 Cfr Part 11 Iso 11137 Iso 11135 Quality Systems Cgmp Iso 9001 Generics Governmental Affairs 5s

Bernard Sagaert Education Details

  • Vlerick Business School
    Vlerick Business School
    Advanced Management Program
  • Fagg - Afmps
    Fagg - Afmps
    Qualified Person
  • Fagg - Afmps
    Fagg - Afmps
    Qualified Person For Pharmacovigilance
  • Fagg - Afmps
    Fagg - Afmps
    Responsible For The Pharmaceutical Information
  • Université Catholique De Louvain
    Université Catholique De Louvain
    Master In Administration (Iag)
  • Ku Leuven
    Ku Leuven
    Pharmacy

Frequently Asked Questions about Bernard Sagaert

What company does Bernard Sagaert work for?

Bernard Sagaert works for Etherna

What is Bernard Sagaert's role at the current company?

Bernard Sagaert's current role is CEO at etherna - Senior Consultant and CEO at Inphacon bv - Board member.

What is Bernard Sagaert's email address?

Bernard Sagaert's email address is be****@****ail.com

What schools did Bernard Sagaert attend?

Bernard Sagaert attended Vlerick Business School, Fagg - Afmps, Fagg - Afmps, Fagg - Afmps, Université Catholique De Louvain, Ku Leuven.

What are some of Bernard Sagaert's interests?

Bernard Sagaert has interest in Culture In General, Culture In Generalsportshealthy Food, Culture In General Sports Healthy Food, Wine.

What skills is Bernard Sagaert known for?

Bernard Sagaert has skills like Regulatory Affairs, Gmp, Pharmaceutical Industry, Quality Assurance, Quality System, Medical Devices, Pharmaceutics, Quality Management, Capa, Validation, Fda, Iso 13485.

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