Experience

Vera Therapeutics, Inc.

• United States
• Biotechnology
• 1 - 100 Employee

• Associate Director, Clinical Supply Chain

  • Aug 2023 - Present

• Sr. Manager, Clinical Supply Chain

  • Jun 2022 - Aug 2023

  Brisbane, California, United States



Amgen

• United States
• Biotechnology Research
• 700 & Above Employee

• Sr. Associate, Clinical Supply Chain

  • Apr 2021 - May 2022

  • Global Study Planner for 20 complex, Fastlane, global Phase 1,2, and 3 studies. • Forecast Finished Drug Product demand based on clinical enrollment and region via Anaplan. • Monitor inventory, process work orders, and initiate depot shipments via SAP. • Collaborate with cross functional teams and manage aggressive timelines to ensure supply is available for every patient. • Coordinate supply strategies due to unforeseen delays or changes in demand, manufacturing, or raw… Show more • Global Study Planner for 20 complex, Fastlane, global Phase 1,2, and 3 studies. • Forecast Finished Drug Product demand based on clinical enrollment and region via Anaplan. • Monitor inventory, process work orders, and initiate depot shipments via SAP. • Collaborate with cross functional teams and manage aggressive timelines to ensure supply is available for every patient. • Coordinate supply strategies due to unforeseen delays or changes in demand, manufacturing, or raw material. • Served as the single supply chain point of contact to successfully integrate Five Prime studies with Amgen processes and systems. • Troubleshoot IXRS issues and oversee manual workarounds to maintain healthy IP supply levels at depots and sites. • Provide proforma invoice templates to study teams for global import license submissions. Show less



Five Prime Therapeutics, Inc.

• Sr. Associate, Clinical Supply Chain

  • Aug 2019 - Apr 2021

  South San Francisco • Clinical supply lead for global Phase 1-3 studies. • Forecasted IMP demand based on clinical study protocol. • Created, monitored, and adapted supply plans to support clinical demand. • Developed clinical label text and IMP kit designs to comply with regulations and global requirements. • Collaborated with external CMO vendors to manage labeling/packaging operations and comparator sourcing. • Managed DS/DP/FDP/Sample shipments within the global distribution network and… Show more • Clinical supply lead for global Phase 1-3 studies. • Forecasted IMP demand based on clinical study protocol. • Created, monitored, and adapted supply plans to support clinical demand. • Developed clinical label text and IMP kit designs to comply with regulations and global requirements. • Collaborated with external CMO vendors to manage labeling/packaging operations and comparator sourcing. • Managed DS/DP/FDP/Sample shipments within the global distribution network and resolved any temperature excursion issues. • Coordinated drug returns and drug reconciliation at end of study. • Performed budget tracking for cost of clinical supply chain operations, approved invoices, and created purchase orders. • Provided oversight on drug IRT enhancements and design. • Implemented process improvement to digitalize temperature excursion review and disposition. • Oversaw project management of an accelerated DP manufacturing timeline using MS Project to minimize potential IP stockout. Show less



Clovis Oncology

• United States
• Biotechnology Research
• 1 - 100 Employee

• Clinical Supplies Associate

  • Dec 2017 - Aug 2019

  Oakland, CA • Coordinated distribution of Investigational Product to depots and sites for clinical studies, Investigator-Initiated Trials, and Named Patient programs within tight timelines. • Performed product label development for clinical supplies by drafting master label text, obtaining translations, performing character by character verification, and routing for subsequent reviews and approvals. • Processed temperature excursions on-site and in-transit by dispositioning drug appropriately, filing… Show more • Coordinated distribution of Investigational Product to depots and sites for clinical studies, Investigator-Initiated Trials, and Named Patient programs within tight timelines. • Performed product label development for clinical supplies by drafting master label text, obtaining translations, performing character by character verification, and routing for subsequent reviews and approvals. • Processed temperature excursions on-site and in-transit by dispositioning drug appropriately, filing documentation, and monitoring trends. • Resolved deviations by performing investigations and/or CAPAs. • Collaborated with Clinical Operations, Quality Assurance, Regulatory Affairs, vendors, and clinical service providers to ensure supplies are available to sites in a timely manner. • Reviewed invoices and quotes. Show less



Pharmacyclics

• Clinical Document Control Associate I

  • Apr 2017 - Dec 2017

  South San Francisco Performed updates to the Master TMF Index based off the DIA reference model; Managed TMF room files, maintenance, and security access for all clinical trials.



Eurofins Lancaster Laboratories

• United States
• Biotechnology Research
• 700 & Above Employee

• Scientist III, Consultant at Genentech

  • May 2015 - Apr 2017

  South San Francisco Coordinated and managed multiple on-going stability studies.

• Scientist II, Consultant at Genentech

  • Dec 2013 - May 2015

  South San Francisco Provided high quality technical, scientific services to Genentech on a daily basis by conducting late-stage protein formulation development to support licensure of commercial drug products.



C S Bio Co

• Quality Control Chemist I

  • Jun 2012 - Dec 2013

  Menlo Park, CA Performed routine, analytical tests including RP-HPLC, MS, GC, and KF to check quality of peptides under cGMP requirements



ConAgra Foods

• United States
• Manufacturing
• 1 - 100 Employee

• Quality Control Analyst

  • Nov 2011 - May 2012

  Oakland, CA Conducted technical and chemical analyses of bulk, package, and raw flour samples meeting customer requirements