Sander Vader

Experience

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  Solvay Pharmaceuticals

  Sept 1996 - Jul 1997

  Trainnee

  Bioanalytical sample preparation and analysis and method development

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  Solvay Pharmaceuticals

  Apr 1999 - Oct 1999

  Trainnee

  Development and implementation of a database within SQL*LIMS

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  Vital Scientific BV

  Jan 2000 - Aug 2000

  Trainnee

  Development and implementation of an automated system for testing clinical chemical analysers

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  Solvay Pharmaceuticals

  Aug 2000 - Oct 2009

  - Responsible for managing conduct, calculation, interpretation and study monitoring of pre-clinical pharmacokinetic and safety pharmacology studies- Responsible for data management, laboratory automation and computer validation according to 21 CFR Part 11- Key User WinNonlin - Responsible for the conduct of the analysis of small molecules with HPLC (with DAD, UV or ECD) and for method development (including sample preparation with liquid-liquid or solid phase extraction)- Responsible for data management, laboratory automation and computer validation according to 21 CFR Part 11

  • Senior Analyst

    Jan 2002 - Oct 2009

  • Study Director

    Aug 2000 - Dec 2001
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  Abbott Laboratories

  Nov 2009 - Aug 2011

  Scientist Safety Pharmacology

  Scientist Safety Pharmacology within the Clinical Candidate Selection unit.- Responsible for managing conduct, scientific content and study monitoring of in- and external pre-clinical core battery and add-on safety pharmacology studies from lead optimization up to phase 1- Managing pre-clinical safety pharmacology projects and translating project requests to clear objectives for the technicians- Responsible for operational management of technicians conducting safety pharmacology studies- Responsible for the proposal and validation of new internal in-vivo safety pharmacology models- Responsible for the Safety Pharmacology part in the Non Clinical section of Investigator’s Brochures- GLP coordinator, responsible for maintaining GLP compliance within the unit- Chairman of the Safety Pharmacology board within the unit- Contributing member of the “Cardiotoxicity” team of Top Institute Pharma Show less

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  SafetyPharmPlus

  Aug 2011 - Dec 2012

  Co-founder and owner SafetyPharmPlus

  SafetyPharmPlus is an independent contract research organization (CRO) offering sophisticated pre-clinical safety pharmacology models with combined determination of pharmacodynamic and pharmacokinetic properties.

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  The Janssen Pharmaceutical Companies of Johnson & Johnson

  Mar 2013 - Aug 2022

  Supervisor within the Analytical Development unit.- Supervisor Material and Sample Management Team (5.6 FTE), Raw-Materials Team (4.6 FTE) and Outsource Coordination Team (3.1 FTE), my team is mainly responsible for sample receipt, handling, storage & forwarding and ordering, testing and releasing of Raw-materials and Outsource Coordination- Responsibilities included: Goal and Objective setting, Appraisals, Coaching, Ensuring Compliance (Change Controls and Quality Investigations), improvement projects, cross department alignment, stakeholder management. Show less Outsource Coordinator and Team Lead within the Analytical Development unit.- Responsible for outsourcing Release and Stability studies of Clinical Trial Material according to GMP- Serve a single point of contact between internal stakeholders and external contract parties- Manage, plan and coordinate external testing according to project timelines and ensure smooth communication regarding progress, maintain up to date planning and KPI’s- Support and translate contract requests from internal stakeholders to clear objectives for external parties and challenge required efforts and/or costs - Organize and chair face-to-face meetings or technical visits between internal stakeholders and external parties- Support Global QA as co-auditor for external contract laboratories- Serve as Subject Matter Expert for outsourcing activities - Team Lead Material and Sample Management Team (3.6 FTE) and Raw-Materials Team (4.7 FTE), my team is mainly responsible for sample receipt, handling, storage & forwarding and ordering, testing and releasing of Raw-materials Show less Outsource Coordinator and Team Lead within the Analytical Development unit.- Responsible for outsourcing Release and Stability studies of Clinical Trial Material according to GMP- Serve a single point of contact between internal stakeholders and external contract parties- Manage, plan and coordinate external testing according to project timelines and ensure smooth communication regarding progress, maintain up to date planning and KPI’s- Support and translate contract requests from internal stakeholders to clear objectives for external parties and challenge required efforts and/or costs- Organize and chair face-to-face meetings or technical visits between internal stakeholders and external parties- Support Global QA as co-auditor for external contract laboratories- Serve as Subject Matter Expert for outsourcing activities Show less

  • Manager Sample Management and Coordination Team

    Mar 2021 - Aug 2022

  • Manager Raw Materials, Sample Management and Outsource Coordination Team

    Oct 2020 - Mar 2021

  • Supervisor Raw Materials, Sample Management and Outsource Coordination Team

    Apr 2018 - Oct 2020

  • Outsource Coordinator and Team Lead

    Mar 2015 - Mar 2018

  • Outsource Coordinator

    Mar 2013 - Feb 2015
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  Johnson & Johnson Innovative Medicine

  Aug 2022 - Mar 2024

  Commercial Technical Integrator (Analytical Development)

  Representing Analytical Development within the CMC teams for our Ebola (ZABDENO and MVABEA) and COVID (JCOVDEN) vaccine. In this role I am responsible for managing and execution of analytical deliverables and coordinating a smooth transfer from late stage to commercial launch in line with the project strategy and planning. This includes activities for analytical development, QC (development), stability studies (shelf-life extensions), agency responses and regular reports, writing and managing change controls and Quality Investigations.From JUL2023 - APR2024Support Drug Substance Development as Technical Integrator In this role I am responsible for the GMP readiness of the manufacturing facility for saRNA products. Show less

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  Bristol Myers Squibb

  Mar 2024 - now

  Senior Manager QC Sample Management & Scheduling