Joanne Lu

Experience

• 

  Bristol-Myers Squibb

  Mar 2004 - Mar 2006

  QA Specialist/Compliance Engineer

  As a Compliance Engineer, led deviation investigations, driving to an accurate and complete root cause analysis and appropriate CAPA assignment. As a QA Specialist, reviewed investigation reports for completeness and served as an SME of the deviation system during an FDA PAI audit.

• 

  Amgen

  Apr 2006 - Oct 2007

  Plant Engineer

  Provided daily support to manufacturing by ensuring process equipment reliability. Knowledge of process as well as equipment was required to troubleshoot equipment issues and investigate deviations. Responsible for reviewing work orders, validation protocols, and automation changes for equipment impact.

• 

  Abbott Bioresearch Center

  Nov 2007 - Dec 2007

  Validation Engineer

  Briefly worked in a temporary position in validation to close out validation reports

• 

  Merck

  Jan 2008 - now

  Driving development of integrated CMC and clinical strategies through portfolio centric project management Creating an operations organization responsible for enabling delivery of the pipeline at the lowest cost, fastest speed, and highest quality Responsible for late stage commercialization of pipeline products, specifically developing strategy for late stage development, tech transfer, and filing. Lead cross functional team to deliver CMC package of the BLA. Responsible for end to end supply chain, driving supply decisions in alignment with commercial requirements. Collaborate with commercial partners through S&OP process. Optimize working capital while balancing supply continuity. Responsible for leading and executing activities in alignment with long term supply chain strategy, with focus on antibiotic and anesthesia franchises including both commercial and pipeline products. Commercial product support includes, but is not limited to, reduction in end to end lead time, discard avoidance, and source change management. Pipeline product support includes, but is not limited to, site selection decisions, validation and launch strategies, and image selections. Responsible for commercializing drug products from Phase II through commercial launch for both solid dosage forms and therapeutic proteins. Led team to complete process development milestones in support of Phase IIb through commercial launch. Directly supported and manufactured material for clinical trials, planned and executed studies for development of the commercial process, supported tech transfer activities to site, and authored sections of the WMA filing.

  • Executive Director CMC Integrated Project Management

    May 2023 - now

  • Executive Director Commercialization Operations & Process Attribute Sciences

    May 2022 - May 2023

  • Director Large Molecule Pipeline Project Leadership

    Oct 2018 - May 2022

  • Associate Director, Global Vaccines Planning

    Sept 2016 - Sept 2018

  • Sr. Analyst, Supply Chain Management

    Jun 2014 - Sept 2016

  • Development Engineer

    Jan 2008 - May 2014