Leah A.

Experience

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  Amgen

  Mar 2005 - Sept 2005

  Research Associate Intern

  ● Supported laboratory experiment work with conducting refractive index measurements, creating various buffer solutions, and taking viscosity, density and pH measurements of various solutions and experiments.

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  UC Santa Barbara

  Oct 2008 - Mar 2010

  Undergraduate Research Assistant

  ● Assisted in carrying out biochemistry based research projects focused on cloning the Stat1 protein and its various protein interactions. ● Provided support in molecular cloning, protein expression, and data collection using techniques such as PCR, DNA gel electrophoresis, SDS-PAGE, digestion, ligation, transformation of cells and other experiments relating to the Stat1 project. ● Research culminated in a published manuscript in Nucleic Acids Research.

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  Amgen

  Sept 2010 - Dec 2010

  Process Engineer Level III Contract Worker

  ● Responsibilities included taking pH, protein concentration, XRD, and DSE measurements of formulation samples. ● Lead in ordering material and equipment for scale-down.● Conducted various freeze-thaw studies, lyophilization of pre-commerical drug material studies, filling procedures, and other fill-finish unit operations. ● Additional tasks included shipping Amgen novel/proprietary compounds and developed chemical intermediates Amgen sites and non-Amgen sites.

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  Amgen

  Apr 2011 - Dec 2011

  Associate Level II Contract Worker

  DPE pre-commercial and commercial lab manager. ● Conducted gap analysis for equipment owners, operating procedures, and user logbooks. ● Conducted earthquake risk assessment of equipment and devices. ● Placed work orders for device maintenance, conducted safety walkthroughs, managed re-stocking of PPE protection in the pilot plant. ● Created monthly Lab Management Newsletter to DPE department in both Thousand Oaks and Washington sites. ● Updated equipment owner and equipment backup list on Sharepoint and Myteams. ● Created budget proposals and initiated work orders and training for new lab equipment and devices. ● Utilized 5S workplace organization methodology to increase efficiency and effectiveness of equipment and devices of DPE lab. Show less

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  Amgen

  Jul 2012 - now

  As a Senior Program Manager (SPM) in the General Medicine therapeutic area, I was responsible for leading Aimovig® Product Team, as a Global Program Manager (GPM) Director. I also supported Amgen's early pipeline as a SPM for Rozibafusp Alfa's Evidence Generation Team (EGT) and Product Delivery Team (PDT). I have also supported Aimovig®, omecamtiv mecarbil, Parsabiv™ (etelcalcetide), Sensipar®/Mimpara® (cinacalcet), & EPOGEN® (epoetin alfa), and early inflammation pipeline products AMG 592 and AMG 570 (efavaleukin alfa & rozibafusp alfa) in the past. Show less Drive the development and manage the execution of product regulatory filings and of high qualityproject plans in support of the overall program strategy for Commercialization Work Package Teams .● Work with functional leads to develop project plans for deliverables within WPTs● Ensure cross-functional alignment and accountability for timelines and deliverables● Manage and mitigate risks, status summaries and timelines ● Support scenario planning for product teams● Partner and coordinate activities with external business partners and alliances● Provide project information to Leadership for incorporation into deliverables and program timelines● Support work package communications across various functions and regions Show less Project Management responsibilities include supporting Amgen’s Transformational efforts and the Development Design Center (DDC) ● Project management support in advancing the progress of multiple deliverables related to study outline and protocol implementation, risk assessment documentation and implementation, and adaptive design implementation across the development portfolio.● Experience with working on multiple projects simultaneously and at various stages of maturity. ● Experience with working with many cross-functional and global stakeholders. ● Participated in face to face meeting with TransCelerate consortium on Risk Based Monitoring. ● Developed content, facilitated and supported a two-day global workshop to support the Risk Assessment project. ● Previous Lead for program management in support of Study Design and Feasibility. Show less ● Managed three budgets within the cardiovascular therapeutic area (TA). ● Coordinated global publication team activities including: meeting logistics, slide development, database entries, and metrics generation. ● Responsible for liaising with internal meeting management department and external vendors.● Ensured submission and follow up communication materials for material approval and review process. ● Assisted with scientific congress preparations (e.g., support congress status update meetings with internal stakeholders, vendor management, logistics support, slide development for plan/status updates). ● Managed logistics for Congress Booth Activities, such as: coordinated congress booth material approval and review submissions, and coordinated materials for use in congress booth, including material lists, shipping, and vendor communications. ● Maintained the cardiovascular TA SharePoint sites, EDMteams sites, calendars, and deliverable timelines. Show less

  • Global Program Management Director

    Sept 2022 - now

  • Senior Global Program Manager - Commercialization & Program Management

    Jul 2018 - Sept 2022

  • Project Manager - Strategy, Commercialization & Innovation

    Jun 2017 - Jun 2018

  • Project Manager - Development Design Center

    Dec 2014 - Jun 2017

  • Senior Associate Project Management

    Jul 2012 - Dec 2014