Michael Wasko

Experience

• 

  White Eagle Laboratories

  Mar 1999 - Jul 2002

  Toxicology Technician
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  Sanofi-aventis

  Aug 2002 - Mar 2012

  Scientist

  Conducted general, reproductive, and cytotoxic toxicology studies from initiation, through protocol generation, study conduct, and through reporting phases. Performed technical procedures (dosing, sample collection, observations, cesarian sections) as part of study conduct.Drafted and executed validations on equipment and systems.Served as member of site wide validation team charged with developing working tools, templates, and guidance for validations across the US site as well as collaborating with the global validation team to harmonize validation processes and documentation across the company.Trained and mentored less experienced staff. Ordered and maintain consumables for the laboratory.Maintained equipment and computers and coordinated calibrations of equipment.Served as main collector of ECG data from preclinical toxicology studies and member of ECG team.Generated statistical tables to aid in the reporting process.Trouble shot and corrected data collection system errors and problems.Very proficient in MS office, Provantis (super user), Ponemah, e-Room, Standard DocMan, ProWatt, Ariba (punchout catalog purchasing), Colada, Tick@lab, S@T-tox, ProWatt, GDMS, Amegaview and statistical software. Show less

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  Educational Institution

  Mar 2012 - Jun 2013

  Preclinical Toxicology Scientist / Validation Professional

  Experienced toxicology scientist with extensive equipment and systems validation experience seeking position to expand upon knowledge and experience.

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  PDS Pathology Data Systems Ltd

  Jun 2013 - Jun 2015

  Product Specialist

  Provide product support and validation support to PDS LIMS software clientsServe as product owner for assigned products.Assist with guiding development team to needs of clients for future products and upcoming versions.Perform in-house validation of products as well as training and assisting clients with validations.Creation of SEND datasets. Keep a pulse on needs of industry. Participation in SEND organizations such as CDISC and PhUSE.

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  PDS Life Sciences

  Jun 2015 - Sept 2021

  Responsible for all SEND products and services, while heavily responsible for all US operations. Involved and supervised all aspects of the SEND business, including but not limited to TranSEND software specifications, demonstrations, and implementations. Established, mentored and lead a dynamic team performing SEND services achieving all customer needs and timelines, to aid customer with their regulatory submissions. Served as a leader, Scientific and SEND Expert, and mentor for a large team. Involved in most executive decisions within PDS, including forecasting and future strategies. Owned or heavily participated in all SEND business oversight from first customer contact, through demonstration and sales processes including presenting at trade shows, to execution of sale, and management of product and/or services execution. Grew the SEND business to a primary source of revenue, expanding and upskilling team to support the business. Show less

  • Director, SEND

    Apr 2018 - Sept 2021

  • Senior Product Manager

    Dec 2016 - Apr 2018

  • Product Manager

    Jun 2015 - Dec 2016
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  Instem

  Sept 2021 - Oct 2024

  Responsible for managing the operational components of services for In Silico services including but not limited to KnowledgeScan. Managed a global team, supporting customer needs, new solution development, service improvement, and implementation. Involvement in all potential service offering opportunities including assessment, SOWs, pricing, resource planning, project management, forecasting, revenue recognition. Focus on expanding skillsets of team, to improve efficiencies, faster work flows, and increase team engagement. Review metrics of performance of team members, financial metrics of projects, in addition to capacity modelling. Aided in implementation of new service offerings, and contributor to future strategies. Show less

  • Director, Outsourcing Services - In Silico Solutions

    Jan 2023 - Oct 2024

  • Director, SEND

    Sept 2021 - Mar 2023