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Building on everything we learned responding to a global pandemic to reinvent biopharma operations so that any company can move at unprecedented speed…
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FounderStealth Mode Jan 2024 - Present -
Chief Architect, Vice PresidentModerna Therapeutics Oct 2021 - Sep 2023Cambridge, Massachusetts, Us -
Vice President, Business And Gxp SystemsModerna Therapeutics Jan 2017 - Oct 2021Cambridge, Massachusetts, Us -
Head Of Tech Ops Innovation, Architecture And AnalyticsShire May 2015 - Jan 2017Tokyo, Jp, Jp -
Director, Technical Operations ItShire Jan 2013 - May 2015Tokyo, 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 -
Associate Director, Controlled ApplicationsShire Feb 2007 - Jan 2013Tokyo, 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 -
Sr. Laboratory Informatics ConsultantBiogen Idec Aug 2004 - Feb 2007Cambridge, 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 -
Sr. Solutions ArchitectFleetmax 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
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Lead Technical ArchitectBreakaway 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 -
Application EngineerKewill Systems 1998 - 2000
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System AdministatorAlg Company 1996 - 1998
Roland Smith Skills
Roland Smith Education Details
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Worcester Polytechnic InstituteBiotechnology -
Cornell Johnson Graduate School Of ManagementMaster 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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