Roland Smith

Roland Smith Email and Phone Number

Founder @ Stealth Mode
Roland Smith's Location
Boston, Massachusetts, United States, United States
Roland Smith's Contact Details
About Roland Smith

Building on everything we learned responding to a global pandemic to reinvent biopharma operations so that any company can move at unprecedented speed…

Roland Smith's Current Company Details
Stealth Mode

Stealth Mode

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Founder
Roland Smith Work Experience Details
  • Stealth Mode
    Founder
    Stealth Mode Jan 2024 - Present
  • Moderna Therapeutics
    Chief Architect, Vice President
    Moderna Therapeutics Oct 2021 - Sep 2023
    Cambridge, Massachusetts, Us
  • Moderna Therapeutics
    Vice President, Business And Gxp Systems
    Moderna Therapeutics Jan 2017 - Oct 2021
    Cambridge, Massachusetts, Us
  • Shire
    Head Of Tech Ops Innovation, Architecture And Analytics
    Shire May 2015 - Jan 2017
    Tokyo, Jp, Jp
  • Shire
    Director, Technical Operations It
    Shire Jan 2013 - May 2015
    Tokyo, Jp, Jp
    • Recruited, developed and retained high performing team of 20+ staff including: software developers, solution architects, technical writers and application support specialists• Developed hybrid sourcing strategy for solution delivery and support of complex 250+ application / 2000+ user / 46 project regulated portfolio resulting in >$2M in annual savings • Developed multi-year digital laboratory strategy to transform process and technology • Developed and executed strategy to deploy next generation qualified infrastructure and operations framework resulting in significant improvements in compliance, efficiency and application performance• Managed annual $25 million dollar operating and capital budget
  • Shire
    Associate Director, Controlled Applications
    Shire Feb 2007 - Jan 2013
    Tokyo, Jp, Jp
    • Delivered cross-functional global implementations of laboratory (LabWare), quality management (TrackWise), document management (Quamas), training management, human resources and manufacturing solutions • Deployed structured, risk based software testing methodology resulting in reusable approach to streamline application testing resulting in 10% reduction in solution deployment times • Designed and implemented change management process and web-based tools to enable a 30% increase in annual master data updates without requiring additional headcount • Led several process improvement initiatives including drug stability process re-design, global change control process re-design, training process re-design and US/EU exception process harmonization
  • Biogen Idec
    Sr. Laboratory Informatics Consultant
    Biogen Idec Aug 2004 - Feb 2007
    Cambridge, Ma, Us
    • Managed numerous successful LIMS projects for QC, Stability, Validation, Manufacturing, Team Supply, PST, AD, Virology and Raw Material groups• Supported 400 user LIMS community including the creation and maintenance of Raw Material, In Process, Developmental Stability and Release tests and workflows in a GMP controlled environment• Designed numerous custom reports to streamline business processes and report on critical data
  • Fleetmax Software
    Sr. Solutions Architect
    Fleetmax Software 2001 - 2004
    • Led end user support model improvements resulting in 30% reduction in resolution cycle time and 50% reduction of repeat issues within one year • Facilitated process design workshops and planning sessions to assist more than 30 customer sites through solution design, report development and software implementation • Designed, implemented and delivered training programs nationwide for asset management software solutions
  • Breakaway Solutions
    Lead Technical Architect
    Breakaway Solutions Jan 2000 - Mar 2001
    • Managed design and development (4 developers) of core components for a managed services product offering, including a web based portal allowing users to view and change system monitoring profiles• Rebuilt system monitoring and backup infrastructures for 11 world wide data centers from the ground up resulting in decreased down time and improved outage response time• Partnered with C-level clients to determine solution requirements and coordinated across business groups to ensure implementation met customer expectations
  • Kewill Systems
    Application Engineer
    Kewill Systems 1998 - 2000
  • Alg Company
    System Administator
    Alg Company 1996 - 1998

Roland Smith Skills

21 Cfr Part 11 Change Control Lims Validation Fda Biopharmaceuticals Computer System Validation Biotechnology Capa Quality System Gmp Pharmaceutical Industry Quality Assurance Technology Transfer Gxp Glp Sop Technological Innovation Software Development Data Analytics

Roland Smith Education Details

  • Worcester Polytechnic Institute
    Worcester Polytechnic Institute
    Biotechnology
  • Cornell Johnson Graduate School Of Management
    Cornell Johnson Graduate School Of Management
    Master Of Business Administration (Mba)

Frequently Asked Questions about Roland Smith

What company does Roland Smith work for?

Roland Smith works for Stealth Mode

What is Roland Smith's role at the current company?

Roland Smith's current role is Founder.

What is Roland Smith's email address?

Roland Smith's email address is rg****@****ine.net

What is Roland Smith's direct phone number?

Roland Smith's direct phone number is +163187*****

What schools did Roland Smith attend?

Roland Smith attended Worcester Polytechnic Institute, Cornell Johnson Graduate School Of Management.

What skills is Roland Smith known for?

Roland Smith has skills like 21 Cfr Part 11, Change Control, Lims, Validation, Fda, Biopharmaceuticals, Computer System Validation, Biotechnology, Capa, Quality System, Gmp, Pharmaceutical Industry.

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