Jeff Schumack

Jeff Schumack Email and Phone Number

Vice President of Clinical and Molecular Diagnostics Systems at BioIT Solutions, Inc @ BioIT Solutions, Inc
silver spring, maryland, united states
Jeff Schumack's Location
Rockville, Maryland, United States, United States
Jeff Schumack's Contact Details
About Jeff Schumack

Jeff Schumack has over 30 years experience in the IT industry, primarily in the Biotechnology sector. His experience includes managing complex projects, leading multi-disciplinary teams, building validation programs in response to regulations including FDAs 21 CFR, Part 11, architecture and development of custom laboratory software, and a deep understanding of business processes used by Clinical Research & Development organizations.

Jeff Schumack's Current Company Details
BioIT Solutions, Inc

Bioit Solutions, Inc

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Vice President of Clinical and Molecular Diagnostics Systems at BioIT Solutions, Inc
silver spring, maryland, united states
Website:
bioit.com
Employees:
7
Jeff Schumack Work Experience Details
  • Bioit Solutions, Inc
    Vice President Of Professional Services
    Bioit Solutions, Inc May 2010 - Present
    Silver Spring, Md
  • Bioit Solutions, Inc
    Principal Consultant
    Bioit Solutions, Inc May 2010 - Sep 2012
    As Principal Consultant for a startup company which specializes in Laboratory Information Management Systems (LIMS), applied knowledge of laboratory operations and Clinical LIMS development to expand the BioIT WebLIMS platform.
  • Human Genome Sciences, Inc.
    Associate Director, It Applications
    Human Genome Sciences, Inc. 1998 - May 2010
    Directed the newly formed IT Systems group in managing IT Applications business analysts for all applications across the organization.• Responsible for managing eight employees supporting various systems analysis, systems integration and project management activities.• Assumed responsibilities for Drug Development, Manufacturing Operations, Human Resources, Finance and Business Development systems. Major applications include, SAP, Documentum, Impact, Insight Publisher, Qumas, Trackwise, Plateau, ADP, Clintrial and ARISg.
  • Human Genome Sciences
    Senior Software Engineer
    Human Genome Sciences Jan 1998 - Nov 2001
    Responsible for all systems integration, software development and general information technology support for the Clinical, Regulatory Affairs and Manufacturing groups. Recruited and managed two software engineers to in support of these projects.• Created the MIDAS data analysis system for the Biostatistics department. This system increases the efficiency of laboratory data analysis by allowing scientists to archive and analyze statistical data instantly based on HGS standard analysis guidelines.• Created the Batch Records and Issuance Control System (BRICS) that controls the issuance of paper based Batch Records for use in the Quality Assurance and Manufacturing groups.• Managed the development of a Lotus Notes based Clinical Trial Manager system for the Clinical Operations group.• Developed the Final Report Generation System for the Biostatistics group and several research organizations. This system compiled information from Sybase and Oracle data sources into a preformatted Microsoft Word document called the Pre-clinical Final Study Report used in support of HGS INDs.• Developed systems to increase the efficiency and enforce standards for the software development team. The Data Dictionary System tracked all systems, table, field and index definitions for custom HGS systems. This system generated SQL scripts that create all objects for a system including, roles, triggers, tables, fields and indexes for custom Oracle or Sybase systems. The Oracle System Administration System combined Oracle role based security with HGS custom system requirements.• Directed the project team for integrating the Waban Software Statistical Computing Environment for the Biostatistics group. Worked with the Biostatistics group to re-engineer their business processes in preparation for the production use of the system. Worked with Waban Software in creating a design specification that involved significant changes to their core system to better address HGS needs.

Jeff Schumack Skills

Biotechnology Validation Pharmaceutical Industry 21 Cfr Part 11 Clinical Trials Lims Biopharmaceuticals Clinical Development Drug Development Quality Assurance Integration Regulatory Affairs Fda Life Sciences Lifesciences Business Process Glp Genomics Change Control Computer System Validation Technology Transfer Data Analysis Gxp Oracle Clinical Research Ind Clinical Data Management Team Leadership

Jeff Schumack Education Details

Frequently Asked Questions about Jeff Schumack

What company does Jeff Schumack work for?

Jeff Schumack works for Bioit Solutions, Inc

What is Jeff Schumack's role at the current company?

Jeff Schumack's current role is Vice President of Clinical and Molecular Diagnostics Systems at BioIT Solutions, Inc.

What is Jeff Schumack's email address?

Jeff Schumack's email address is je****@****ail.com

What is Jeff Schumack's direct phone number?

Jeff Schumack's direct phone number is +124046*****

What schools did Jeff Schumack attend?

Jeff Schumack attended Michigan State University.

What skills is Jeff Schumack known for?

Jeff Schumack has skills like Biotechnology, Validation, Pharmaceutical Industry, 21 Cfr Part 11, Clinical Trials, Lims, Biopharmaceuticals, Clinical Development, Drug Development, Quality Assurance, Integration, Regulatory Affairs.

Who are Jeff Schumack's colleagues?

Jeff Schumack's colleagues are Bob Beliveau, Charlie Boucher.

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